NCT01482715

A Study of Oral Rucaparib in Patients With gBRCA Mutation Breast Cancer or Other Solid Tumor

Study identifier: NCT01482715
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Rucaparib (previously PF-01367338)

Eligibility:

• Locally recurrent or metastatic solid tumor (includes lymphoma, all types of breast cancer) that has progressed on standard treatment (Part 1)
  OR
• Locally advanced or metastatic breast cancer that is associated with a gBRCA mutation and that has relapsed following prior treatment, is not HER2+, and is measurable (Part 2).

Type of study:

Phase I/II single-agent. Single group assignment (all participants receive study agent).

Treatment:
Oral tablet administered daily; 21-day cycles of treatment. In Part 1, the initial dose level is 40 mg/day; doses will be escalated in subsequent patient cohorts until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. Patients enrolled in Part 2 will receive the RP2D daily for continuous 21-day treatment cycles..

Study sites:

Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Entela Rama ramae@karmanos.org

Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Julie Pfrommer julie.pfrommer@scresearch.net

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