Spots Global Cancer Trial Database for A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.
Official Title: 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
Study ID: NCT03840200
Study Description
Brief Summary: 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).
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Roma, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2, Milano, Lombardia, Italy
Azienda Ospedaliera Santa Maria di Terni, Terni, Umbria, Italy
Istituto Oncologico Veneto IRCCS, Padova, Veneto, Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Universitario Virgen de la Victoria, Malaga, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
