Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial
Cancer drugs which target the effects of abnormal gene changes are called 'targeted therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are currently available. The purpose of this study is to find out what are the effects on a patient and their cancer when they are given a targeted therapy drug that is specific to an abnormal gene change in their cancer.
• Adult (≥ 18 yrs) patient with a histologically-proven incurable metastatic solid tumour (excluding primary brain tumours), multiple myeloma or B cell non-Hodgkin lymphoma (excluding CLL, SLL and HCL), for whom there is no standard treatment known to prolong life, or who has refused such treatment.
• ECOG performance status 0-2.
• Patients must have normal organ function as follows:
‣ Absolute neutrophil count: ≥ 1.5 x 10\^9/L for solid tumours; ≥ 1.0 x 10\^9/L for neurologic malignancies
⁃ Platelets ≥ 75 x 10\^9/L (or ≥ 50 x 10\^9/L if bone marrow involvement by myeloma or lymphoma).
⁃ Total bilirubin ≤ 1.5 x UNL.
⁃ AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal value unless liver metastases are present in which case they must be \< 5 x ULN;
⁃ Serum creatinine ≤ 1.5 x UNL or calculated or measured creatinine clearance ≥ 50mg/min/1.73µ\^2
• Patients must have measurable disease
• Results must be available from tumour genomic or protein expression testing (if used to identify genetic variants), from one of the initiatives / groups listed in protocol Appendix VII. The test may have been performed on the primary tumour or a metastatic deposit (including bone marrow), or blood, in a diagnostic or research laboratory and must reveal a potentially actionable variant.
• Patient consent (Main Study Consent for the screening step) must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to the screening step to document their willingness to participate
• Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre or a CCTG IND site. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
• Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.