NCT01482715 - A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II) | Biotech Hunter

Enrollment

136

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

March 31, 2019

Study Completion Date

May 31, 2019

Conditions

Ovarian CancerFallopian Tube CancerPeritoneal CancerAdvanced Solid Tumor With Evidence of Germline or Somatic BRCA

Interventions

DRUG

Rucaparib

Oral tablets administered daily with 8 oz (240 mL) of water on an empty stomach or with food; 21-day cycles of treatment. In Part 1, the initial dose level is 40 mg/day (once a day); doses and dosing frequency(e.g. twice a day or three times a day) will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. Patients enrolled in Part 2 and Part 3 will receive the RP2D for continuous 21-day treatment cycles until disease progression.

Trial Locations (16)

8035

Hospital Vall d'Hebron, Barcelona

19104

University of Pennsylvania, Philadelphia

34232

Sarah Cannon Research Institute, Sarasota

37203

Sarah Cannon Research Institute, Nashville

48201

Karmanos Cancer Institute, Detroit

52621

Sheba Medical Center, Ramat Gan

94155

UCSF, San Francisco

632394

Tel Aviv Sourasky Medical Center, Tel Aviv

02215

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

MSG 2M9

Princess Margaret Cancer Centre, Toronto

SE1 9RT

Guy's and St Thomas NHS Foundation Trust, London

SW3 6JJ

Royal Marsden NHS Foundation Trust, London

W12 0HS

Imperial College Healthcare, London

UK NE7

Newcastle University, Newcastle upon Tyne

G61 1QH

Institution of Cancer Science, University of Glasgow Wolfson Wohl Cancer Research, Glasgow

WC1E 6BT

University College London Cancer Institute, London