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Spots Global Cancer Trial Database for A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II)

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Trial Identification

Brief Title: A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II)

Official Title: A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor

Study ID: NCT01482715

Interventions

Rucaparib

Study Description

Brief Summary: Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors. Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic). Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).

Detailed Description: Rucaparib (CO-338; formerly known as PF 01367338 and AG 14699) is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination \[HR\] DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with BRCA1 or BRCA2 mutations. For this study, it is anticipated that rucaparib will promote cell death in the BRCA-deficient tumor cells of ovarian cancer patients with evidence of a germline mutation, thereby limiting tumor progression and providing therapeutic benefit.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

UCSF, San Francisco, California, United States

Sarah Cannon Research Institute, Sarasota, Florida, United States

Dana-Farber Cancer Institute (Part 3 only), Boston, Massachusetts, United States

Karmanos Cancer Institute, Detroit, Michigan, United States

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute, Nashville, Tennessee, United States

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Sheba Medical Center, Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel

Hospital Vall d'Hebron, Barcelona, , Spain

Guy's and St Thomas NHS Foundation Trust, London, England, United Kingdom

Royal Marsden NHS Foundation Trust, London, England, United Kingdom

Imperial College Healthcare, London, England, United Kingdom

Newcastle University, Newcastle Upon Tyne, England, United Kingdom

Institution of Cancer Science, University of Glasgow Wolfson Wohl Cancer Research, Glasgow, Scotland, United Kingdom

University College London Cancer Institute, London, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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