Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
NCT03297606
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
613-533-6430
(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.
(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
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
- Augusta, Maine
- York, Maine
- Manchester, New Hampshire
- Birmingham, Alabama
- Phoenix, Arizona
- Los Angeles, California
- San Francisco, California
- Miami, Florida
- Atlanta, Georgia
- Atlanta, Georgia
- Honolulu, Hawaii
- Chicago, Illinois
- Indianapolis, Indiana
- Ann Arbor, Michigan
- Grand Rapids, Michigan
- Traverse City, Michigan
- Omaha, Nebraska
- Charlotte, North Carolina
- Bismarck, North Dakota
- Fargo, North Dakota
- Tulsa, Oklahoma
- Portland, Oregon
- Allentown, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Sioux Falls, South Dakota
- Houston, Texas
- Salt Lake City, Utah
- Fairfax, Virginia
- Seattle, Washington
- Edmonton, Alberta
- Vancouver, British Columbia
- Kingston, Ontario
- London, Ontario
- Ottawa, Ontario
- Toronto, Ontario
- Montreal, Quebec
- Regina, Saskatchewan
- Saskatoon, Saskatchewan
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 |
| ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE |
| ||||||
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 | 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)
Exclusion Criteria: (screening step - non-drug specific)
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
| ||||||
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 |
| ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Canadian Cancer Trials Group | ||||||
Study Sponsor ICMJE | Canadian Cancer Trials Group | ||||||
Collaborators ICMJE |
| ||||||
Investigators ICMJE |
| ||||||
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 |