A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

April 27, 2017

Primary Completion Date

August 11, 2020

Study Completion Date

August 11, 2020

Conditions
Gynecologic Neoplasms
Interventions
DRUG

Atezolizumab

Atezolizumab 1200 mg (equivalent to an average body weight-based dose of 15 milligrams per kilogram \[mg/kg\]) will be administered by IV infusion once every 3 weeks, corresponding to a 21-day treatment cycle. Participants will receive atezolizumab starting on Cycle 1, Day 1. Participants deriving clinical benefit will be allowed to continue on study treatment until the absence of unacceptable toxicity or compelling evidence of disease progression.

DRUG

Rucaparib

The starting dosage level of rucaparib for Part 1 is 400 mg PO BID during a 21-day treatment cycle. During Part 1, the rucaparib doses were increased up to a maximum of 600 mg PO BID using a standard 3 + 3 dose escalation. RP2D was identified as 600 mg BID. During Part 2 of the study, rucaparib will be dosed at the RP2D determined in Part 1. Participants in Part 1 of the study will receive rucaparib starting on Cycle 1, Day 1. During Part 2, participants will receive rucaparib monotherapy during a 21-day run-in period. After completion of the rucaparib run-in period and the first on-treatment biopsy between Days 15 and 21 of the run-in period, participants will begin Cycle 1, Day 1 of the rucaparib. Participants deriving clinical benefit will be allowed to continue on study treatment until the absence of unacceptable toxicity or compelling evidence of disease progression.

Trial Locations (11)

3000

Peter Maccallum Cancer Centre, Melbourne

31620

Clínica Universidad de Navarra, Pamplona

69008

Centre Leon Berard, Lyon

69310

Centre Hospitalier Lyon Sud; Service d'Oncologie Médicale, Pierre-Bénite

94800

Gustave Roussy, Villejuif

08035

Hospital Universitario Vall d'Hebron, Barcelona

Unknown

La Paz University Hospital, Madrid

SW3 6JJ

Royal Marsden Hospital - London, London

WC1E 6AU

University College London Hospitals NHS Foundation Trust - University College Hospital, London

PR2 9HT

Lancashire Teaching Hospitals NHS Foundation Trust, Preston

SM2 5PT

Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03101280 - A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer | Biotech Hunter | Biotech Hunter