Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Cross Cancer Institute
RECRUITING
Edmonton
BCCA - Kelowna
RECRUITING
Kelowna
Kingston Health Sciences Centre
RECRUITING
Kingston
London Health Sciences Centre Research Inc.
RECRUITING
London
The Jewish General Hospital
RECRUITING
Montreal
Ottawa Hospital Research Institute
RECRUITING
Ottawa
Allan Blair Cancer Centre
RECRUITING
Regina
Saskatoon Cancer Centre
RECRUITING
Saskatoon
University Health Network
RECRUITING
Toronto
BCCA - Vancouver
RECRUITING
Vancouver
Contact Information
Primary
Janet Dancey
jdancey@ctg.queensu.ca
613-533-6430
Time Frame
Start Date: 2018-03-23
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 720
Treatments
Experimental: Group 1 - Arm CLOSED, no patients recruited
VEGFR1, VEGFR2, VEGFR3
Experimental: Group 2 - Arm CLOSED, no patients recruited
BCR-ABL, SRC
Experimental: Group 3 - Arm CLOSED
ALK, ROS1, MET
Experimental: Group 4 - Arm CLOSED, no patients recruited
KIT, PDGFRA, PDGFRB, ABL1
Experimental: Group 5 - Arm CLOSED
EGFR
Experimental: Group 6 - Arm CLOSED
high mutation burden, POLE, POLD1
Experimental: Group 7 - Arm CLOSED
BRCA1, BRCA2, mutations in HRD
Experimental: Group 8 - Arm CLOSED
CDKN2A, CDK4, CCND1, SMARCA4
Experimental: Group 9 Arm CLOSED
CSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL
Experimental: Group 10 Arm CLOSED
AKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STK11, TSC1, TSC2
Experimental: Group 11 - Arm CLOSED
ERBB2
Experimental: Group 12 - Arm CLOSED
BRAFV600
Experimental: Group 13 - Arm CLOSED
PTCH1, SMO
Experimental: Group 14
ERBB2
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb, Hoffmann-La Roche, Pfizer, Seagen Inc., AstraZeneca
Leads: Canadian Cancer Trials Group

This content was sourced from clinicaltrials.gov

Similar Clinical Trials