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 — DRUG
    All 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: Rucaparib
    All 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)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Mayo ClinicRochesterMinnesota55902-
New York UniversityNew YorkNew York10012-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
MD Anderson Cancer CenterHoustonTexas77030-

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