PM1

PM1 Details
Status: Open
Activation Date: 2017OCT06
Phase: II

Description: Canadian Profiling and Targeted agent Utilization tRial (CAPTUR). A Phase II Basket Trial.

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.

Objective: 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.

Participation: Limited to invited centres

Lay Description: 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.

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Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
OTHERS	PM1	Open Trial	0	0	0

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(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
OTHERS	PM1	Open Trial	0	0

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Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
OTHERS	PM1	Open Trial	377	0	0	0	376	0	0	0