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

Part of paid clinical trials in San Francisco, California.

Sponsor
pharmaand GmbH
Study ID
NCT01482715
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumor With Evidence of Germline or Somatic BRCA
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    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.

Study Details

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).

Key Dates

Start date
Nov 30, 2011
Status verified
Jun 2023
Primary completion
Mar 31, 2019
Completion
May 31, 2019

Study Design

Enrollment
136 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Phase 1)
    Rucaparib 40, 80, 160, 300, 500 mg QD and 240, 360, 480, 600, 840 mg BID, for continuous 21-day cycles. Patients in Part 1 were initially treated in a Dose-escalation Evaluation Period (Cycle 1) and could then continue to receive treatment in an optional Treatment-extension Period (Cycle 2 and beyond).
  • Experimental: Part 2A (Phase 2)
    Rucaparib 600 mg BID for 21-day cycles.
  • Experimental: Part 2B (Phase 2)
    Rucaparib 600 mg BID for 21-day cycles.
  • Experimental: Part 3 (Phase 2)
    Rucaparib 600 mg BID for 21-day cycles. Patients also received a single administration of 600 mg rucaparib on both Day -7 and Day 1 for assessing the effect of food on PK.

Primary Outcome Measure

Overall Response Rate Per RECIST Version 1.1 (Part 2) [ Time Frame: Time from first dose to date of progression, up to approximately 8 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
UCSFSan FranciscoCalifornia94155-
Sarah Cannon Research InstituteSarasotaFlorida34232-
Dana-Farber Cancer Institute (Part 3 only)BostonMassachusetts02215-
Karmanos Cancer InstituteDetroitMichigan48201-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in San Francisco, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
UCSF· San Francisco, CASarah Cannon Research Institute· Sarasota, FLDana-Farber Cancer Institute (Part 3 only)· Boston, MAKarmanos Cancer Institute· Detroit, MIUniversity of Pennsylvania· Philadelphia, PASarah Cannon Research Institute· Nashville, TN

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