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Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR)

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ClinicalTrials.gov Identifier: NCT03297606
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
AstraZeneca
Bristol-Myers Squibb
Hoffmann-La Roche
Pfizer
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE September 29, 2017
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE October 6, 2017
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
Objective response rate defined as the number of patients with complete response or partial response [ Time Frame: 4 years ]
over the total number of patients in the given tumour type cohort.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03297606 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
  • Number and severity of adverse events [ Time Frame: 4 years ]
    measured by CTCAE
  • Progression-free survival confirmed by disease-appropriate objective criteria [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
Official Title  ICMJE Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial
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.
Detailed Description Recent advances in laboratory technology have enabled the identification of changes in the genetic makeup of tumors that might be responsible for their malignant behavior such as uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be cancer medicines that can specifically act on the tumour's genetic abnormality. Several cancer centers and programs have initiated this type of molecular profiling across Canada, with the goal to identify 'druggable' changes in tumors to find matching therapy for patients. These include initiatives in British Columbia, Ontario and Quebec for adult tumours, as well as a pan-Canadian profiling centre for pediatrics. The CAnadian Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of commercially available targeted agents in patients who have undergone tumor profiling by one of the above mentioned programs, and have 'druggable' changes identified in their cancers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Advanced Solid Tumors
Intervention  ICMJE
  • Drug: Olaparib
    300mg taken twice daily
  • Drug: Dasatinib
    100mg administered orally once daily
  • Drug: Nivolumab plus Ipilimumab
    • Combination Phase - 1mg/kg nivolumab administered as an intravenous infusion over 60 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 3mg/kg administered intravenously over 90 minutes, followed by the single-agent phase.
    • Single-Agent Phase - 3mg/kg nivolumab administered as an IV infusion over 60 minutes every 2 weeks.
  • Drug: Axitinib
    5mg orally twice daily
  • Drug: Bosutinib
    500mg orally once daily
  • Drug: Crizotinib
    250mg orally twice daily
  • Drug: Palbociclib
    125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
  • Drug: Sunitinib
    50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off
  • Drug: Temsirolimus
    25mg infused over a 30-60 minute period once a week
  • Drug: Erlotinib
    150mg orally, once daily
  • Drug: Trastuzumab plus Pertuzumab

    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.

  • Drug: Vemurafenib plus Cobimetinib

    Vemurafenib = 960 mg orally every 12 hours.

    Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest

  • Drug: Vismodegib
    150mg taken orally, once daily
Study Arms  ICMJE
  • Experimental: Group 1
    VEGFR1, VEGFR2, VEGFR3
    Intervention: Drug: Axitinib
  • Experimental: Group 2
    BCR-ABL, SRC
    Intervention: Drug: Bosutinib
  • Experimental: Group 3
    ALK, ROS1, MET
    Intervention: Drug: Crizotinib
  • Experimental: Group 4
    KIT, PDGFRA, PDGFRB, ABL1
    Intervention: Drug: Dasatinib
  • Experimental: Group 5
    EGFR
    Intervention: Drug: Erlotinib
  • Experimental: Group 6
    high mutation burden, POLE, POLD1
    Intervention: Drug: Nivolumab plus Ipilimumab
  • Experimental: Group 7
    BRCA1, BRCA2, mutations in HRD.
    Intervention: Drug: Olaparib
  • Experimental: Group 8
    CDKN2A, CDK4, CDK6, CCND1
    Intervention: Drug: Palbociclib
  • Experimental: Group 9
    CSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL
    Intervention: Drug: Sunitinib
  • Experimental: Group 10
    AKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STKII, TSC1, TSC2
    Intervention: Drug: Temsirolimus
  • Experimental: Group 11
    ERBB2
    Intervention: Drug: Trastuzumab plus Pertuzumab
  • Experimental: Group 12
    BRAFV600
    Intervention: Drug: Vemurafenib plus Cobimetinib
  • Experimental: Group 13
    PTCH1, SMO
    Intervention: Drug: Vismodegib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2017)
720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: (screening step - non-drug specific)

  • 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 and bone marrow function measured within 4 weeks prior to administration of study treatment as follows:
  • Hemoglobin ≥ 100.0 g/L with no blood transfusions (packed red blood cells and platelet transfusions) in the past 28 days prior to start of study treatment;
  • Absolute neutrophil count:

    • 1.5 x 10^9/L
  • No features suggestive of MDS/AML on peripheral blood smear;
  • Platelets ≥ 100 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 alone is not sufficient for eligibility. Patients matched to olaparib must have creatinine clearance estimated of ≥ 51 mL/min using the Cockcroft‐Gault equation or based on a 24 hour urine test.
  • Adequate hepatic function assessed by:
  • total serum bilirubin ≤ 2.0 the upper limit of normal (UNL), unless resulting from hemolysis, Gilbert's syndrome, or live infiltration with tumour
  • aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x the upper limit of normal (ULN)
  • 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 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.

Exclusion Criteria: (screening step - non-drug specific)

  • Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Janet Dancey 613-533-6430 jdancey@ctg.queensu.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03297606
Other Study ID Numbers  ICMJE PM1
ESR‐17‐12831 ( Other Identifier: AstraZeneca )
CA209‐9DL ( Other Identifier: Bristol-Myers Squibb )
ML39800 ( Other Identifier: Hoffmann-La Roche )
WI233446 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Canadian Cancer Trials Group
Study Sponsor  ICMJE Canadian Cancer Trials Group
Collaborators  ICMJE
  • AstraZeneca
  • Bristol-Myers Squibb
  • Hoffmann-La Roche
  • Pfizer
Investigators  ICMJE
Study Chair: Lillian Siu Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
Study Chair: Daniel J Renouf BCCA - Vancouver Cancer Centre, Vancouver BC, Canada
PRS Account Canadian Cancer Trials Group
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP