Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

NCT03297606

Last updated date
Study Location
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Contact
613-533-6430

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

613-533-6430

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin Lymphoma, Multiple Myeloma, Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

(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 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

(screening step - non-drug specific)


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Non-Hodgkin Lymphoma, Multiple Myeloma, Advanced Solid TumorsTAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
NCT02693535
  1. Augusta, Maine
  2. York, Maine
  3. Manchester, New Hampshire
  4. Birmingham, Alabama
  5. Phoenix, Arizona
  6. Los Angeles, California
  7. San Francisco, California
  8. Miami, Florida
  9. Atlanta, Georgia
  10. Atlanta, Georgia
  11. Honolulu, Hawaii
  12. Chicago, Illinois
  13. Indianapolis, Indiana
  14. Ann Arbor, Michigan
  15. Grand Rapids, Michigan
  16. Traverse City, Michigan
  17. Omaha, Nebraska
  18. Charlotte, North Carolina
  19. Bismarck, North Dakota
  20. Fargo, North Dakota
  21. Tulsa, Oklahoma
  22. Portland, Oregon
  23. Allentown, Pennsylvania
  24. Philadelphia, Pennsylvania
  25. Philadelphia, Pennsylvania
  26. Sioux Falls, South Dakota
  27. Houston, Texas
  28. Salt Lake City, Utah
  29. Fairfax, Virginia
  30. Seattle, Washington
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Non-Hodgkin Lymphoma, Multiple Myeloma, Advanced Solid TumorsCanadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
NCT03297606
  1. Edmonton, Alberta
  2. Vancouver, British Columbia
  3. Kingston, Ontario
  4. London, Ontario
  5. Ottawa, Ontario
  6. Toronto, Ontario
  7. Montreal, Quebec
  8. Regina, Saskatchewan
  9. Saskatoon, Saskatchewan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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. 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 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 - 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.
  • 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, CCND1, SMARCA4
    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, STK11, 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 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.

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

  • 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.
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 Dancey613-533-6430[email protected]
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:No
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 SiuUniv. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
Study Chair:Daniel J RenoufBCCA - Vancouver Cancer Centre, Vancouver BC, Canada
PRS Account Canadian Cancer Trials Group
Verification Date September 2020

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