A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- pharmaand GmbH
- Study ID
- NCT02042378
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rucaparib — DRUGAll patients will take oral tablets twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Study Details
The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.
Key Dates
- Start date
- Apr 30, 2014
- Status verified
- Jun 2023
- Primary completion
- Apr 30, 2016
- Completion
- May 31, 2016
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: RucaparibAll patients will take oral tablets twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Primary Outcome Measure
Overall Response Rate (ORR) per RECIST v1.1 as assessed by the investigator [ Time Frame: Screening, within 7 days prior to the start of every 3rd cycle of treatment, and Treatment Discontinuation Visit. Study to last for ~3 years. ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | - |
| Mayo Clinic | Rochester | Minnesota | 55902 | - |
| New York University | New York | New York | 10012 | - |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | - |
| MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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