Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Sponsor
Canadian Cancer Trials Group
Study ID
NCT03297606
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 23, 2018
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
720 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Objective response rate defined as the number of patients with complete response or partial response [ Time Frame: 4 years ]

Central Contacts

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