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New treatment option for Lymphoma, Non-Hodgkin
Official title Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
ClinicalTrials.gov ID: NCT03297606
What this study is testing
What is Olaparib?
Olaparib is an investigational medicine, given as an once-daily, being studied as a potential treatment for lymphoma, non-hodgkin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (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...
- 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
You likely can't join if
- (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 how well it works...
- Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy or asymptomatic, corrected biochemical toxicities (e.g...
- Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for...
- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient...
- Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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 how well it works 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...
- 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...
- 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...
- 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...
- Lactating and nursing women
- Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Kelowna, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Kingston, Ontario, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Regina, Saskatchewan, Canada
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Kingston, Ontario, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.