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Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

ConditionsLymphoma, Non-HodgkinMultiple MyelomaAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olaparib

    Drug

    300mg taken twice daily

  • Dasatinib

    Drug

    100mg administered orally once daily

  • 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.

  • Axitinib

    Drug

    5mg orally twice daily

  • Bosutinib

    Drug

    500mg orally once daily

  • Crizotinib

    Drug

    250mg orally twice daily

  • Palbociclib

    Drug

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

  • Sunitinib

    Drug

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

  • Temsirolimus

    Drug

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

  • Erlotinib

    Drug

    150mg orally, once daily

  • 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.

  • 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

  • Vismodegib

    Drug

    150mg taken orally, once daily

  • Tucatinib

    Drug

    300mg taken orally, twice daily

Treatment groups

720 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: Group 1 - Arm CLOSED, no patients recruitedExperimental treatment 1 intervention
Group B: Group 2 - Arm CLOSED, no patients recruitedExperimental treatment 1 intervention
Group C: Group 3 - Arm CLOSEDExperimental treatment 1 intervention
Group D: Group 4 - Arm CLOSED, no patients recruitedExperimental treatment 1 intervention
Group E: Group 5 - Arm CLOSEDExperimental treatment 1 intervention
Group F: Group 6 - Arm CLOSEDExperimental treatment 1 intervention
Group G: Group 7 - Arm CLOSEDExperimental treatment 1 intervention
Group H: Group 8 - Arm CLOSEDExperimental treatment 1 intervention
Group I: Group 9 Arm CLOSEDExperimental treatment 1 intervention
Group J: Group 10 Arm CLOSEDExperimental treatment 1 intervention
Group K: Group 11 - Arm CLOSEDExperimental treatment 1 intervention
Group L: Group 12 - Arm CLOSEDExperimental treatment 1 intervention
Group M: Group 13 - Arm CLOSEDExperimental treatment 1 intervention
Group N: Group 14Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
4 years

Secondary outcomes

1

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

measured by CTCAE

Time frame
4 years
2

Progression-free survival by disease-appropriate objective criteria

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

AstraZeneca

Collaborator

Bristol-Myers Squibb

Collaborator

Hoffmann-La Roche

Collaborator

Pfizer

Collaborator

Seagen Inc.

Collaborator

Source ClinicalTrials.gov
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