Clinical Trials /

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

NCT03297606

Description:

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Malignant Solid Tumor
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
  • Official Title: Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial

Clinical Trial IDs

  • ORG STUDY ID: PM1
  • SECONDARY ID: ESR‐17‐12831
  • SECONDARY ID: CA209‐9DL
  • SECONDARY ID: ML39800
  • SECONDARY ID: WI233446
  • NCT ID: NCT03297606

Conditions

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

Interventions

DrugSynonymsArms
OlaparibGroup 7
DasatinibGroup 4
Nivolumab plus IpilimumabGroup 6
AxitinibGroup 1
BosutinibGroup 2
CrizotinibGroup 3
PalbociclibGroup 8
SunitinibGroup 9
TemsirolimusGroup 10
ErlotinibGroup 5
Trastuzumab plus PertuzumabGroup 11
Vemurafenib plus CobimetinibGroup 12
VismodegibGroup 13

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Group 1ExperimentalVEGFR1, VEGFR2, VEGFR3
  • Axitinib
Group 2ExperimentalBCR-ABL, SRC
  • Bosutinib
Group 3ExperimentalALK, ROS1, MET
  • Crizotinib
Group 4ExperimentalKIT, PDGFRA, PDGFRB, ABL1
  • Dasatinib
Group 5ExperimentalEGFR
  • Erlotinib
Group 6Experimentalhigh mutation burden, POLE, POLD1
  • Nivolumab plus Ipilimumab
Group 7ExperimentalBRCA1, BRCA2, mutations in HRD.
  • Olaparib
Group 8ExperimentalCDKN2A, CDK4, CDK6, CCND1
  • Palbociclib
Group 9ExperimentalCSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL
  • Sunitinib
Group 10ExperimentalAKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STKII, TSC1, TSC2
  • Temsirolimus
Group 11ExperimentalERBB2
  • Trastuzumab plus Pertuzumab
Group 12ExperimentalBRAFV600
  • Vemurafenib plus Cobimetinib
Group 13ExperimentalPTCH1, SMO
  • Vismodegib

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate defined as the number of patients with complete response or partial response
Time Frame:4 years
Safety Issue:
Description:over the total number of patients in the given tumour type cohort.

Secondary Outcome Measures

Measure:Number and severity of adverse events
Time Frame:4 years
Safety Issue:
Description:measured by CTCAE
Measure:Progression-free survival confirmed by disease-appropriate objective criteria
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Canadian Cancer Trials Group

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