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A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Rucaparib in Patients With Advanced Breast, Ovarian, or Prostate Cancer
This is a study in participants with advanced breast, ovarian, or prostate cancer to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of ipatasertib in combination with rucaparib. The study consists of two parts: a Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer and a Dose-Expansion Phase (Part 2) in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide).
There are two parts in the study. A Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer. There will be a 7-day run-in period with ipatasertib alone prior to Cycle 1, Day 1. After the completion of the ipatasertib run-in period, participants will begin Cycle 1, Day 1 of the ipatasertib and rucaparib combination treatment. Each cycle has 28 days. Participants will be split into 4 cohorts: Dose Level 1 group - 300 mg ipatasertib once daily (QD) + 400 mg rucaparib twice daily (BID), Dose Level 2a: 300 mg ipatasertib QD + 600 mg rucaparib BID, Dose Level 2b: 400 mg ipatasertib QD + 400 mg rucaparib BID, Dose Level 3: 400 mg ipatasertib QD + 600 mg rucaparib BID A Dose-Expansion Phase (Part 2) - The recommended dose identified in Part 1 (highest dose level of ipatasertib and rucaparib with an acceptable safety profile and less than one-third of participants experience a dose limiting toxicity) will be evaluated in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide). Enrollment in Cohort 3 in dose escalation phase was not opened as one-third of Dose Limiting Toxicity (DLT) evaluable participants receiving the highest dose of rucaparib in Cohort 2a experienced a DLT.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
California Cancer Associates for Research & Excellence, Inc.
San Marcos, California, United States
Regional Cancer Care Associates LLC, Central Jersey Division
East Brunswick, New Jersey, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Mary Crowley Medical Research Center; Oncology
Dallas, Texas, United States
Kinghorn Cancer Centre; St Vincents Hospital
Darlinghurst, New South Wales, Australia
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Istituto Nazionale Tumori Regina Elena IRCCS
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2
Milan, Lombardy, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, Umbria, Italy
Start Date
June 12, 2019
Primary Completion Date
December 7, 2021
Completion Date
January 4, 2022
Last Updated
October 30, 2023
51
ACTUAL participants
Ipatasertib
DRUG
Rucaparib
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT05691465
NCT05039801
Data Source & Attribution
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