Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

NCT03297606 | Recruiting Phase 2 DMC

• 5 other identifiers: PM1ESR-17-12831CA209-9DLML39800WI233446
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Advanced Solid Tumors; Lymphoma, Non-Hodgkin; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Objective response rate defined as the number of patients with complete response or partial response

  over the total number of patients in a given cohort.

  4 years

Secondary Outcomes (2)

• Number and severity of adverse events grade >3, or of lesser grade resulting in discontinuation, delay or reduction in dose of study drug

  4 years

• Progression-free survival by disease-appropriate objective criteria

  4 years

Study Arms (14)

Group 1 - Arm CLOSED, no patients recruited

EXPERIMENTAL

VEGFR1, VEGFR2, VEGFR3

Drug: Axitinib

Group 2 - Arm CLOSED, no patients recruited

EXPERIMENTAL

BCR-ABL, SRC

Drug: Bosutinib

Group 3 - Arm CLOSED

EXPERIMENTAL

ALK, ROS1, MET

Drug: Crizotinib

Group 4 - Arm CLOSED, no patients recruited

EXPERIMENTAL

KIT, PDGFRA, PDGFRB, ABL1

Drug: Dasatinib

Group 5 - Arm CLOSED

EXPERIMENTAL

EGFR

Drug: Erlotinib

Group 6 - Arm CLOSED

EXPERIMENTAL

high mutation burden, POLE, POLD1

Drug: Nivolumab plus Ipilimumab

Group 7 - Arm CLOSED

EXPERIMENTAL

BRCA1, BRCA2, mutations in HRD

Drug: Olaparib

Group 8 - Arm CLOSED

EXPERIMENTAL

CDKN2A, CDK4, CCND1, SMARCA4

Drug: Palbociclib

Group 9 Arm CLOSED

EXPERIMENTAL

CSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL

Drug: Sunitinib

Group 10 Arm CLOSED

EXPERIMENTAL

AKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STK11, TSC1, TSC2

Drug: Temsirolimus

Group 11 - Arm CLOSED

EXPERIMENTAL

ERBB2

Drug: Trastuzumab plus Pertuzumab

Group 12 - Arm CLOSED

EXPERIMENTAL

BRAFV600

Drug: Vemurafenib plus Cobimetinib

Group 13 - Arm CLOSED

EXPERIMENTAL

PTCH1, SMO

Drug: Vismodegib

Group 14

EXPERIMENTAL

ERBB2

Drug: Tucatinib

Interventions

Axitinib DRUG

5mg orally twice daily

Group 1 - Arm CLOSED, no patients recruited

Bosutinib DRUG

500mg orally once daily

Group 2 - Arm CLOSED, no patients recruited

Crizotinib DRUG

250mg orally twice daily

Group 3 - Arm CLOSED

Palbociclib DRUG

125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days

Group 8 - Arm CLOSED

Sunitinib DRUG

50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Group 9 Arm CLOSED

Temsirolimus DRUG

25mg infused over a 30-60 minute period once a week

Group 10 Arm CLOSED

Erlotinib DRUG

150mg orally, once daily

Group 5 - Arm CLOSED

Trastuzumab plus Pertuzumab DRUG

Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion. Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes.

Group 11 - Arm CLOSED

Vismodegib DRUG

150mg taken orally, once daily

Group 13 - Arm CLOSED

Tucatinib DRUG

300mg taken orally, twice daily

Group 14

Olaparib DRUG

300mg taken twice daily

Group 7 - Arm CLOSED

Dasatinib DRUG

100mg administered orally once daily

Group 4 - Arm CLOSED, no patients recruited

Nivolumab plus Ipilimumab DRUG

* Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase. * Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks.

Group 6 - Arm CLOSED

Vemurafenib plus Cobimetinib DRUG

Vemurafenib = 960 mg orally every 12 hours. Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest

Group 12 - Arm CLOSED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
• Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy or asymptomatic, corrected biochemical toxicities (e.g. hypothyroidism corrected by thyroid replacement), related to prior anti-tumour treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
• Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ one month prior to enrollment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.
• Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.
• Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
• Patients with known left ventricular ejection fraction (LVEF) \< 40%.
• Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.
• Patients with acute gastrointestinal bleeding within one month prior to the screening step.
• Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
• Lactating and nursing women
• Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• AstraZeneca: collaborator
• Bristol-Myers Squibb: collaborator
• Hoffmann-La Roche: collaborator
• Pfizer: collaborator
• Seagen Inc.: collaborator

Study Sites (10)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

BCCA - Kelowna

Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

BCCA - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Interventions

olaparib; Dasatinib; Nivolumab; Ipilimumab; Axitinib; bosutinib; Crizotinib; palbociclib; Sunitinib; temsirolimus; Erlotinib Hydrochloride; Trastuzumab; pertuzumab; Vemurafenib; cobimetinib; HhAntag691; tucatinib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines; Aminopyridines; Pyridines; Pyrroles; Indoles; Quinazolines; Sulfonamides; Sulfones

Study Officials

• Lillian Siu

  Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada

  STUDY CHAIR

• Daniel J Renouf

  BCCA - Vancouver Cancer Centre, Vancouver BC, Canada

  STUDY CHAIR

Central Study Contacts

Janet Dancey

CONTACT

613-533-6430; jdancey@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: September 29, 2017
• Study Start: March 23, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)