Multi-Site Disease Site

Multi-Site

ID Sort	Study Title	Status Sort
I238	A Phase II Study of Durvalumab Substudy A: In Patients who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity Substudy B: For Continued Treatment (+/-) Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies The purpose of this study is to determine if patients who discontinued immunotherapy due to severe side effects related to treatment can be safely retreated with durvalumab and to investigate whether prophylactic steroid use can prevent or reduce new or recurrent side effects. This study will also examine response, progression free survival and explore the relationship between certain biomarkers and outcomes of treatment. Read More Complexity Level: 1 Eligibility: Must live in Canada & received durvalumab +/- tremelimumab, with or without chemo/targeted therapy. Patients who received other PD-1/PD-L1 agents +/- anti-CTLA agents may be eligible, contact CCTG. Had a G3 irAEs that required study drug discontinuation per protocol, selected G4 irAEs, & prolonged G1-2 irAEs where physician/patient wanted to discontinue therapy due to poor tolerability. irAE must have resolved to <= grade 1 or baseline. Completed steroid therapy & have documented CR, PR, or prolonged SD to initial IO therapy. Prior adjuvant/neoadjuvant/consolidation IO is eligible provided a >= 6 mo. treatment free interval prior to enrollment and >= 1 standard of care chemo in the palliative setting (discuss with CCTG if chemo is not SOC or indicated or patient refusal/not eligible). Ineligible if prior G4 non-hematological, non-endocrine irAE, or if required biologic agents to manage irAE, had PD as best response to initial IO, or symptomatic or uncontrolled brain mets. Objectives: Primary: To determine the safety and toxicity profile of rechallenging with durvalumab in patients who previously discontinued immunotherapy due to irAE. Secondary: To determine the objective response rate (RECIST 1.1 and iRECIST); To evaluate the efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs. Tertiary: To explore PFS and iPFS on rechallenge with durvalumab after progression on initial immunotherapy; To explore blood-based and stool-based biomarkers for irAEs; PD-L1 expression. NCT Registration ID (from clinicaltrials.gov): NCT03847649 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: June 07, 2019 Chair: (Canada) Dr. Peter Ellis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495, (Canada) Dr. Sara Taylor, BCCA - Cancer Centre for the Southern Interior, (250) 712-3996	Open to Accrual
I243	A Phase II Study of RP-6306 in Patients with Advanced Cancer The purpose of this study is to test the effects of RP-3606 when given with standard treatment in different types of cancer and to determine if specific biomarkers have an improved response to treatment comparted to those with the biomarker. Read More Complexity Level: 1 Eligibility: Patients (>=18yrs old, ECOG PS0-1), life expectancy >=3 mo., must have advanced/metastatic/recurrent or unresectable cancer, with no curable therapy. All reversible prior toxicity related to prior therapies must have recovered to grade =<1 and have adequate washout. Measurable disease per RECIST 1.1. Consent to release of tissue block and biopsies. Women/men of childbearing potential must have agreed to use an effective contraceptive method. No history of other malignancies or uncontrolled /serious illnesses which would not permit the patient to be managed per protocol. Hypersensitivity to any of the study drug components. No CNS metastases. No pts who are unable to swallow oral meds/have impairment of GI function. No history of non-compliance. Met additional cohort specific eligibility criteria. Objectives: Primary: To determine the response rate of RP-6306 in patients with selected cancers receiving standard agents. Secondary: To determine the safety and tolerability of RP-6306 in patients with selected cancers receiving standard agents; To explore the recommended dose of RP-6306, if indicated. Tertiary: To assess potential biomarkers of response, including but not limited to such as PP2R1A, FBXW7 mutations or CCNE1 amplification / overexpression; To assess efficacy of RP-6306 + FOLFIRI in patients harboring KRAS/TP53/FBXW7 triple mutation; To correlate changes in ctDNA with response.clinical outcomes; To summarize progression-free survival. NCT Registration ID (from clinicaltrials.gov): NCT05605509 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: April 17, 2023 Chair: (Canada) Dr. Stephanie Lheureux, University Health Network, (416) 946-4501 Ext. 2415, (Canada) Dr. Eric (Xueyu) Chen, University Health Network, (416) 946-2263, (Canada) Dr. Yvette Drew, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 4831	Open to Accrual
PM1	Canadian Profiling and Targeted agent Utilization tRial (CAPTUR). A Phase II Basket Trial. Recent advances in laboratory technology have enabled the identification of changes in the genetic makeup of tumors that might be responsible for their malignant behavior such as uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be cancer medicines that can specifically act on the tumour's genetic abnormality. Several cancer centers and programs have initiated this type of molecular profiling across Canada, with the goal to identify 'druggable' changes in tumors and find matching therapy for patients. These include initiatives in British Columbia, Ontario and Quebec. The CAnadian Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of commercially available targeted agents in patients who have undergone tumor profiling and have 'druggable' changes identified in their cancers. Read More Complexity Level: 1 Eligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and have an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug. Objectives: PRIMARY: To evaluate the objective response rate (based on disease-appropriate objective criteria) of targeted drugs matched to pre-specified molecular aberrations (at the level of the gene) within a tumor type, among patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL) with an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug. SECONDARY: (1) To evaluate the safety of commercially available anticancer agents in patients enrolled on CAPTUR; (2) To evaluate progression free survival (PFS) based on disease-appropriate objective criteria. NCT Registration ID (from clinicaltrials.gov): NCT03297606 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: October 06, 2017 Chair: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911, (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 672357	Open to Accrual
PM2	Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated with Immuno-Oncotherapeutics (CAN-IMPACT-IO) The MOHCCN is a national network of Canadian cancer centres that pursues collaborative cancer research in precision medicine (an emerging approach for disease treatment and prevention that considers individual variability in genetic makeup, environment, and lifestyle) to accelerate the discovery of innovations and improve the health outcomes for cancer patients. This network will bring together individual precision medicine projects throughout Canada to ultimately enable clinicians and researchers to predict which treatment strategy will work for which specific patient more accurately. The purpose of this study is to use evolving technologies such as genomics and artificial intelligence to study cancer, so that the right treatment can be given to the right patient, at the right time. Approximately 15,000 participants will take part in this study across Canada in the first 6 years, and the goal is to enroll up to 100,000 over next 10 years. A description of this research study is available at https://www.marathonofhopecancercentres.ca This website will not include information that can identify you as an individual, if you choose to participate. The researchers are interested in examining the genome and transcriptome (DNA and RNA) found in your blood cells and tumour. The study of DNA, RNA and other molecules is often called genomics, transcriptomics and/or multiomics research. Changes in the genome and transcriptome of your tumour before, during and/or post-treatment affect how your body responds to treatment. This study is being done to enable collection and characterization of these samples. The results will be correlated with clinical outcomes of patients with your type of cancer receiving immunotherapy. Read More Complexity Level: 2 Eligibility: CAN-IMPACT-IO is a standalone study of the CCTG, to be performed in collaboration with the Marathon of Hope Cancer Centres Network (MOHCCN) and Princess Margaret Cancer Consortium (PM2C), to perform fresh tumor biopsies for whole genome and transcriptome sequencing (WGTS) analysis for patients enrolled in a specified list of immuno-oncology (IO) therapeutic trials with immune checkpoint inhibitors targeting PD1/PDL1 as single agents or in combination currently active in CCTG. Objectives: Primary Objective -To profile human bodily material (HBM) from patients treated in a specified list of IO therapeutic trials currently active in CCTG, using WGTS either before treatment, during treatment or at time of disease progression with IO to uncover prognostic biomarkers as well as predictive biomarkers of response or resistance. Secondary Objectives -To contribute clinically annotated WGTS data to a unique MOHCCN cohort of 15,000 Canadian cancer patients via PM2C-led Pan-Canadian projects. Tertiary Objectives -To evaluate immune cell populations present in tumoral areas and in the tumor microenvironment (TME) using multiplexed immunohistochemistry (IHC) in a subset of patients treated in a specified list of IO therapeutic trials currently active in CCTG. NCT Registration ID (from clinicaltrials.gov): NCT06630273 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: October 08, 2024 Chair: (Canada) Dr. Anna Spreafico, University Health Network, (416) 946-4501 Ext. 4012, (Canada) Dr. Philippe Bedard, University Health Network, (416) 946-4501 Ext. 4534	Open to Accrual
I206	A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours. Read More Complexity Level: 2 Eligibility: Patients with recurrent, unresectable, locally advanced or metastatic rare tumours: vascular sarcomas (non-pediatric); clear cell carcinomas of ovary, endometrium; medullary thyroid carcinoma; non-pancreatic neuroendocrine tumours: pheochromocytoma, paragangliomas; adrenocortical carcinoma; thymic carcinoma; fibrolamellar hepatocellular carcinoma; rare tumours with somatic mutations in VEGFR, PDGFR, KIT, RET; rare tumours arising from known/suspected germline mutations in PTEN, TS, LKB1, NF1/2. Unidimensionally measurable disease. Archival tissue or fresh biopsy required at study entry. No limit on prior chemotherapy or radiation therapy, although no prior treatment with mTOR inhibitor (for temsirolimus) or VEGFR, PDGFR, RET or KIT inhibitor (for sunitinib) permitted. No uncontrolled hypertension, therapeutic doses of coumadin-derivative anticoagulants, or certain CYP3A4 inhibitors/inducers permitted on sunitinib arm. Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 weeks every 6 weeks and temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent rare tumours. To assess the adverse events, time to progression and response duration of sunitinib orally and temsirolimus given IV weekly in patients with rare tumours. To assess time to first and second progression for patients who receive sunitinib and temsirolimus in sequence. To explore the relationship between genetic alterations in the genome in archival and/or fresh tumour tissue and blood samples from patients on this trial and their objective response to therapy. To assess the consistency of diagnosis of rare tumours through central review of pathology specimens. NCT Registration ID (from clinicaltrials.gov): NCT01396408 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: July 14, 2011 Closing Date: February 05, 2015	Closed to Accrual
I214	A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients with Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours Read More Complexity Level: 1 Eligibility: Patients with histologically confirmed, unresectable locally advanced/metastatic solid tumour (Phase I - Esophogeal/GEJ/gastric, NSCLC and breast, fallopian tube, bladder, adenocystic, anal, melanoma, periampullary, renal, liver, vulvar and ovarian). Tumour must be MAGE-A3 positive. Patient must have have at least one additional tumour mass amenable to core or excisional biopsy and must consent and be willing to undergo at least 2 core biopsies. Patients must have had a least one prior standard first line therapy for advanced/metastatic disease with adequate wash-out period since last dose. Patients must have measurable disease per RECIST 1.1 and adequate organ function. At least 4 weeks since major surgery or radiation therapy. ECOG 0-1. Age >= 18 years. Objectives: Phase I-To determine the recommended phase II dose/schedule and maximum tolerated dose of MG1MA3 alone, AdMA3 alone and in combination. To determine the safety, tolerability, pharmacokinetics (PK) including viral shedding, viral delivery and replication in the tumour cells and anti-tumour activity. Phase II-To assess the anti-tumour activity as evidenced by response rates and further explore the safety profile, PK, cellular and immune response, changes in tumour biomarkers and evaluate overall survival, time to progression by tumour type. NCT Registration ID (from clinicaltrials.gov): NCT02285816 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: October 31, 2014 Closing Date: April 11, 2019 Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168	Closed to Accrual
I226	A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given with or without Standard Chemotherapy Regimens Read More Complexity Level: 1 NCT Registration ID (from clinicaltrials.gov): NCT02537418 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: October 01, 2015 Closing Date: September 06, 2017 Chair: (Canada) Dr. Rosalyn Anne Juergens, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9711 Ext. 64604, (Canada) Dr. Desiree Hao, Tom Baker Cancer Centre, (403) 521-3706	Closed to Accrual
I228	A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours Read More Complexity Level: 2 Eligibility: Clinically and/or radiologically documented disease, with at least one measurable lesion as defined by RECIST 1.1; >=16 years of age; ECOG 0 or 1; no limit on number of prior chemo; No therapy with PD-1/PD-L1 or CTLA-4 inhibitors. No prior autoimmune or inflammatory disorders ie inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome , etc., within the past 3 years prior to the start of treatment. No history of primary immunodeficiency, allogenic organ transplant that requires therapeutic use of IO agents within 28 days. No attenuated vaccination administered within 30 days. No untreated symptomatic brain mets or in whom radiation or surgery is indicated. NO pts with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. Objectives: To evaluate the objective response rate of the combination of durvalumab and tremelimumab given by IV every 4 weeks in patients with rare tumours. To explore the correlation between anti-tumour activity and PD-L1 expression, presence of tumour infiltrating lymphocytes (TILs) and T cell subsets within the tumour. To explore the correlation between anti-tumour activity and genomic alterations in tumour. To assess the consistency of histopathological diagnosis of rare tumours through central review of pathology specimens. To explore the correlation between anti-tumour activity and toxicity with blood based biomarkers. To evaluate the tolerability and safety of durvalumab and tremelimumab combination. To evaluate the effect of durvalumab and tremelimumab combination including time to progression, progression free survival and response duration. NCT Registration ID (from clinicaltrials.gov): NCT02879162 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: October 19, 2016 Closing Date: January 21, 2020 Chair: (Canada) Dr. Abha Gupta, Hospital for Sick Children, (416) 946-2252	Closed to Accrual
PM1S	Insight of the Use and Value of Genomic Analysis in Cancer Patients: A Pan-Canadian Survey of Oncologists and Patients Read More Complexity Level: 3 Eligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and will haveundergone standard testing as indicated by local/provincial practice for diagnosis Medical oncologists must be QIs or SIs active on the PM.1 Participants List and must be from a site which is participating on the PM.1/CAPTUR trial.. Objectives: Primary Objective 1. To determine how Canadian oncologists, from academic cancer centres, use Next-Generation Sequencing (NGS) tests to evaluate patients with metastatic disease who have already undergone standard of care diagnostic testing and inform treatment recommendations, pre- and post-testing. Secondary Objectives 1. To determine patient's satisfaction with their decision-making using a validated tool, pre- and post-NGS testing 2. To obtain feedback from oncologists on the decision impact of NGS and requirements to increase the usage of precision medicine NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: June 08, 2020 Closing Date: May 31, 2022 Chair: (Canada) Dr. Philippe Bedard, University Health Network, (416) 946-4501 Ext. 4534	Closed to Accrual
I101	NCIC CTG Phase I Dose Finding Study of RPR 109881A Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumours Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 23, 1996 Closing Date: March 13, 1998	Permanently Closed
I103	NCIC CTG Phase I Study of BCH-4556 Given as a 30 Minute Infusion Every 3 Weeks Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 27, 1997 Closing Date: March 02, 1999	Permanently Closed
I107	NCIC CTG Phase I Study of BAY 12-9566 in Patients With Advanced Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 27, 1997 Closing Date: December 10, 1997	Permanently Closed
I113	NCIC CTG Phase I Interaction Study Between BAY 12-9566 and Modulated Dose Intensive Fluorouracil (Arm A) or Doxorubicin (Arm B) in Cancer Patients Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 10, 1998 Closing Date: September 20, 1999	Permanently Closed
I115	A Phase I Study of Aplidine Given as a 1 Hour IV Infusion Daily x 5 Days Every 3 Weeks in Patients with Solid Tumours or Low or Intermediate Grade Non-Hodgkin's Lymphoma Refractory to Standard Curative Therapy Read More Eligibility: Histologically or cytologically documented advanced and/or metastatic solid tumours or refractory low/intermediate grade NHL. Prior chemotherapy and radiotherapy permitted. No patients with pre-existing neuropathies permitted. Objectives: To determine the maximum tolerated dose (MTD) of aplidine given as a 1 hour infusion daily x 5 every 3 weeks. To determine safety, toxicity profile and pharmacokinetics of aplidine given in this schedule. To examine efficacy of aplidine given in this schedule. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 15, 1999 Closing Date: February 07, 2002	Permanently Closed
I121	A Phase I Study of LY335979 Administered in Combination With Vinorelbine in Patients With Solid Cancers Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 01, 1999 Closing Date: November 06, 2000	Permanently Closed
I122	A Phase I Study of Oral ZD1839 Given Daily in Patients With Solid Tumours Read More Eligibility: Advanced and/or metastatic solid tumours, expected to have epidermal growth factor receptor (EGFR) mutation/over-expression and tissue accessible for needle biopsy. Prior chemotherapy permissible. Objectives: To determine the biologically active dose range (BADR) as evidence of target effect in a number of clinical correlative studies and MTD (if BADR is not defined prior to MTD) of oral ZD1839 when given daily. To determine safety/toxicity profile, dose limiting toxicities and pharmacokinetics of oral ZD1839. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 14, 1999 Closing Date: June 28, 2001	Permanently Closed
I123	A Phase I Study of NX-211 Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients with Solid Tumours Read More NCT Registration ID (from clinicaltrials.gov): NCT00003891 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 25, 1999 Closing Date: June 09, 2000	Permanently Closed
I124	A Phase I Study of MG98 Given as a 21 Day Continuous IV Infusion in Patients With Advanced Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 11, 1999 Closing Date: May 12, 2000	Permanently Closed
I125	A Phase I Study Of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer Read More NCT Registration ID (from clinicaltrials.gov): NCT00003890 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 22, 1999 Closing Date: March 08, 2001	Permanently Closed
I130	A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory Cancer Read More Eligibility: Patients with advanced refractory cancer. Unidimensionally measurable disease. Prior chemotherapy radiation (< 25 % hematopoietic bone marrow), immunotherapy and surgery permitted. Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of T900607 when given as a 60 minute infusion every 21 days. To evaluate the safety and dose-limiting toxicities (DLT), determine the pharmacokinetics parameters and pharmacodynamic effects. Document preliminary efficacy information and correlate expression of drug resistance markers with response. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 07, 2000 Closing Date: December 19, 2002	Permanently Closed
I131	A Phase I Study of ZD0473 and Docetaxel Given Once Every Three Weeks in Patients With Advanced Refractory Cancer Read More Eligibility: Histologially documented advanced and/or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Up to two prior chemotherapy regimens permitted. Objectives: To determine the maximum tolerated doses and recommended doses of ZD0473 and docetaxel when given in combination to patients with advanced cancer. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 04, 2000 Closing Date: February 08, 2002	Permanently Closed
I133	A Phase I Study of NX211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients With Solid Tumours Read More Eligibility: Histologically or cytologically documented advanced and/or metastatic solid tumours with 1 or less prior chemotherapy regimens. Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of NX211 given in combination with cisplatin on days 1, 2 and 3 every 3 weeks. To describe the toxicity profile, dose limiting toxicities and the pharmacokinetics of NX211 and cisplatin when given in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. Objective tumour response will be assessed in those patients with measurable disease in particular for the patients with small cell lung cancer entered at the level of MTD. NCT Registration ID (from clinicaltrials.gov): NCT00006036 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 22, 2000 Closing Date: November 22, 2001	Permanently Closed
I134	A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three Weeks Read More Eligibility: Histologically documented advanced and/or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Up to two prior chemotherapy regimens permitted. Objectives: To determine the maximum tolerated dose (MTD) and recommended dose of BAY38-3441 when given as a short daily infusion for five days every three weeks to patients with advanced cancer. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 12, 2000 Closing Date: January 16, 2003	Permanently Closed
I144	A Phase I Study of Oral LY293111 Given Daily in Combination With Irinotecan in Patients With Solid Tumours Read More Eligibility: Histologically or cytologically documented evidence of advanced and/or metastatic solid tumours with up to two prior chemotherapy regimens. Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of the combination of irinotecan and LY293111 when IV irinotecan is given on day 1 every 3 weeks and LY293111 is given orally twice daily from the evening of day 2 onward. To determine the toxic effects of this combination and define the duration and reversibility of these effects. To determine the pharmacokinetics of drug-drug interaction of this combination and to assess the clinical response rates in patients with measurable disease treated with this combination. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 23, 2001 Closing Date: June 29, 2004	Permanently Closed
I147	Phase I Study of GS7836 in Patients With Advanced Incurable Solid Tumours Read More Eligibility: Histologically or cytologically documented solid tumour cancer. Clinically or radiologically documented disease. Up to three prior chemotherapy regimens permitted. Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of GS7836 in patients with solid tumours. To determine the safety, tolerability, toxicity profile, dose limiting toxicities and PK profile of GS7836. To assess the anti-tumour activity of GS7836 in patients with measurable disease. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 28, 2001 Closing Date: February 17, 2004	Permanently Closed
I154	A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel Read More Eligibility: Histologic or cytologic evidence of a solid tumour that has been shown to overexpress clusterin (prostate, renal cell, bladder, breast, ovarian cancers). Must have metastatic or locally recurrent disease that is either refractory to standard curative therapy or for which no curative therapy exists. No limit to the number of previous chemotherapy, hormone therapy for patients enrolled to schedule 'A' but limit of <= 2 prior regimens if registered to schedule 'B'. Objectives: To determine the toxicity and define the recommended phase II dose of OGX-011 when given in combination with docetaxel. To determine the pharmacokinetic profile of OGX-011 and weekly docetaxel when administered in combination. To measure evidence of effect on serum clusterin levels and clusterin expression in PBMC and accessible tumours. To document any objective responses. NCT Registration ID (from clinicaltrials.gov): NCT00471432 Participation: Limited to invited centres only. NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 06, 2003 Closing Date: June 28, 2005	Permanently Closed
I166	This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours Read More Eligibility: Patients with histologically documented solid tumours, with locally advanced, metastatic or recurrent disease for which single agent docetaxel therapy is a reasonable therapeutic option. Presence of clinically and/or radiologically documented disease. ECOG performance status 0, 1 or 2. Prior chemotherapy (up to two prior regimens for metastatic/recurrent disease, and one regimen for adjuvant treatment, but no more than one taxane-containing regimen) is permitted. Prior surgery, hormone therapy, immunotherapy and radiation therapy are permitted. Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AEG35156 administered intravenously in combination with docetaxel. NCT Registration ID (from clinicaltrials.gov): NCT00357747 Participation: Participation in this phase I study is restricted to invited centres. NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 04, 2005 Closing Date: July 10, 2006	Permanently Closed
I166B	This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours Read More Eligibility: Patients with histologically documented solid tumours, with locally advanced, metastatic or recurrent disease for which single agent docetaxel therapy is a reasonable therapeutic option. Presence of clinically and/or radiologically documented disease. ECOG performance status 0, 1 or 2. Prior chemotherapy (up to two prior regimens for metastatic/recurrent disease, and one regimen for adjuvant treatment, but no more than one taxane-containing regimen) is permitted. Prior surgery, hormone therapy, immunotherapy and radiation therapy are permitted. Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AEG35156 administered intravenously in combination with docetaxel. NCT Registration ID (from clinicaltrials.gov): NCT00372736 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 20, 2006 Closing Date: March 20, 2008	Permanently Closed
I177	A Phase I Study Of AT7519M Given Twice Weekly In Patients With Advanced Incurable Malignancy Read More Complexity Level: 1 Eligibility: Advanced/metastatic solid tumour or non-Hodgkins lymphoma. Patients with solid tumours may not have had more than 2 prior regimens for metastatic disease; patients with non-Hodgkins lymphoma must have, in the opinion of the investigator, failed all standard therapies. Objectives: To determine the safety, tolerability, toxicity profile and define a recommended phase II dose of AT7519M given as a one hour infusion twice weekly for two weeks every 21 days in patients with advanced incurable malignancy. NCT Registration ID (from clinicaltrials.gov): NCT00390117 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 22, 2006 Closing Date: April 04, 2011	Permanently Closed
I179	Phase I Study Of CCI-779 In Combination With Carboplatin And Paclitaxel In Patients With Advanced Solid Tumours. Read More Eligibility: Patients with histological confirmed advanced solid tumours for which therapy with carboplatin and paclitaxel is a reasonable therapeutic option (at expanded cohort at recommended dose: endometrial cancer or ovarian cancer patients only). Measurable or non-measurable disease (except in expanded cohort at recommended dose: all patients must have measurable disease). Objectives: To establish the maximum tolerated dose (MTD) and recommended phase II dose (RPTD) of CCI 779 in combination with carboplatin and paclitaxel, administered intravenously on day 1 of a three week cycle, in patients with advanced solid cancers. To describe the frequency and severity of toxic effects of the combination of carboplatin, paclitaxel and CCI-779 given at the recommended dose and schedule. To document any evidence of objective antitumour activity of the combination of CCI-779 with carboplatin and paclitaxel, in those patients with measurable disease. To determine the pharmacokinetic profile of carboplatin, paclitaxel alone and with CCI-779 co-administration within patients, and to determine the pharamacokinetic profile of CCI-779 alone and with carboplatin and paclitaxel co-administration within the same patients. NCT Registration ID (from clinicaltrials.gov): NCT00408655 Participation: Limited to invited centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 25, 2006 Closing Date: March 27, 2009	Permanently Closed
I181	NCIC CTG Phase I Study Of AT9283 Given As A 24 Hour Infusion On Days 1 And 8 Every Three Weeks In Patients With Advanced Incurable Malignancy Read More Eligibility: Advanced and/or metastatic solid tumours; non-Hodgkin's lymphoma judged to be refractory to standard therapies. Up to two prior chemotherapy regimens for metastatic disease permitted in patients with solid tumours; no chemotherapy limitations for non-Hodgkin's lymphoma patients. Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks in patients with advanced incurable malignancy. NCT Registration ID (from clinicaltrials.gov): NCT00443976 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 04, 2007 Closing Date: November 24, 2009	Permanently Closed
I188	A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced Cancer Read More Eligibility: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumours, refractory to standard therapy or for which conventional therapy is not effective. No anti-cancer treatment <= 28 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No pre-exisitng peripheral neuropathy >= gr 2. Objectives: 1.1 The primary objective of this study is to determine the recommended phase II dose of oral SB939 in patients with solid tumours. SB939 will be administered initially for 3 consecutive days every other week and then for 5 consecutive days every other week at escalating doses. 1.2 To determine the toxic effects of SB939 given in this schedule, their association with dose and pharmacokinetics 1.3 To assess the pharmacokinetic profile of SB939 given in this schedule 1.4 To assess preliminary evidence of anti-tumour effects in patients with measurable disease by documentation of objective response 1.5 To establish proof-of-principle for SB939 effects on histone acetylation by evaluation of histone acetylation and other biomarkers in peripheral blood mononuclear cells (PBMCs) at all dose levels and in tumour tissue at the recommended phase II dose level NCT Registration ID (from clinicaltrials.gov): NCT00504296 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 21, 2007 Closing Date: March 16, 2010	Permanently Closed
I203	A Phase I Study of SB939 in Pediatric Patients with Refractory Solid Tumours and Leukemia. Read More Complexity Level: 1 Eligibility: Part A. Patients must have recurrent or refractory solid tumours, lymphoma or CNS tumours (excluding diffuse intrinsic pontine gliomas). Part B. Patients must have recurrent or refractory leukemia. Part C. Patients must have neuroblastoma, or medulloblastoma/CNS primitive neuroectodermal tumour (PNET). All patients must have histologic verification of malignancy, adequate bone marrow, renal, cardiac and liver function, and must meet all other eligibility criteria as defined in Protocol Section 5. Objectives: Part A. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of oral SB939 in pediatric patients with solid tumours, with SB939 administered orally every other day three times/week for three consecutive weeks, followed by one week off-dosing. Part B. To assess the tolerability of the solid tumour RP2D in patients with recurrent or refractory leukemia once the RP2D has been established in solid tumours. Part C. To determine the RP2D of oral SB939 in combination with a fixed dose of 13-cis-retinoic acid in children with refractory or recurrent neuroblastoma, medulloblastoma/CNS neuroectodermal tumour (PNET), using the recommended dose determined in Part A of this study. To characterize the pharmacokinetics of SB939 in a pediatric population. To describe any antitumour activity of SB939 in pediatric tumours when given as a single agent, and when given in combination with 13-cis-retinoic acid. NCT Registration ID (from clinicaltrials.gov): NCT01184274 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 21, 2010 Closing Date: January 25, 2012	Permanently Closed
I212	A Pilot Study of Imetelstat given Intravenously on Day 1 and 8 of a 21 Day Schedule Alone and With Standard 13-Cis-Retinoic Acid in Children with Recurrent and/or Refractory Neuroblastoma. Read More Complexity Level: 1 Eligibility: Patients must have recurrent or refractory neuroblastoma which is histologically verified at either original diagnosis or relapse. Objectives: 1.1 In patients with relapsed and/or refractory neuroblastoma, to confirm the feasibility of administering imetelstat given at the recommended pediatric dose as determined in the Children's Oncology Group Study ADVL1112 (a phase I study of imetelstat, a telomerase inhibitor, in children with recurrent or refractory solid tumours and lymphoma), alone and in combination with 13-cis-retinoic acid. 1.2 In patients with relapsed and/or refractory neuroblastoma to assess the impact of imetelstat on hematopoietic stem cells and neuroblastoma tumour initiating cells. 1.3 In patients with relapsed and/or refractory neuroblastoma to evaluate: - The correlation of tumour and plasma C-circles. - The role of plasma C-circles as a tumour biomarker for alternative lengthening of telomeres (ALT). - Changes in plasma C-circles induced by treatment with imetelstat. NCT Registration ID (from clinicaltrials.gov): NCT01916187 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 30, 2013 Closing Date: November 22, 2013	Permanently Closed
I32	NCIC CTG Phase I Study of Trimetrexate Glucuronate Daily x 9 Bolus Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 01, 1985 Closing Date: December 01, 1985	Permanently Closed
I36	NCIC CTG Phase I Study of Didemnin-B Weekly x 4 q 6 wks Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 01, 1986 Closing Date: November 29, 1991	Permanently Closed
I43	NCIC CTG Phase I Study of CI-937 Bolus q 3 to 4 wks Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 19, 1988 Closing Date: August 10, 1990	Permanently Closed
I44	NCIC CTG Phase I Study of CI-937 Given Weekly x 3 Every 5 Weeks Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 18, 1988 Closing Date: March 11, 1991	Permanently Closed
I67	NCIC CTG Phase I Study Of Fostriecin Given as an Intravenous Bolus Daily for 5 Consecutive Days Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 10, 1992 Closing Date: May 21, 1996	Permanently Closed
I85	A Phase I Study of BMS-182751 (JM-216) and Etoposide in Patients With Previously Untreated Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 22, 1994 Closing Date: November 08, 1994	Permanently Closed
I86	NCIC CTG Phase I Study of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) Formulation Given as a 24 Hour Continuous Infusion Weekly x 4 Every 5 Weeks Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 13, 1995 Closing Date: October 28, 1996	Permanently Closed
I96	NCIC CTG Phase I Study of JM216 Plus VP16(Etoposide) Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 15, 1996 Closing Date: June 03, 1999	Permanently Closed

Recently Activated Trials

Planned Trials

ALC9

BLC6

BR38

HE2

HN13

MD1

Multi-Site

CANADIAN CANCER TRIALS GROUP

A NATIONAL PROGRAM OF THE:

OPERATIONS AND STATISTICAL CENTRE LOCATED AT:

PROUDLY AFFILIATED WITH: