NCT03840200 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Breast,Female reproductive organs,Urinary systemBreast,Ovary,Prostate

Trial Overview Read MoreRead more

This phase I trial is trying to determine the dose of two combined oral therapies (ipatasertib and rucaparib) as a treatment for advanced breast, ovarian or prostate cancer.
 

This trial is treating multiple types of cancer including breast, prostate or ovarian cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific 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

Commercial Sponsor

Hoffmann-La Roche

Summary

This is a dose escalation and expansion trial. Before Cycle 1, Part 1, eligible (advanced breast cancer, ovarian cancer, or prostate cancer) patients will receive a 7-day run-in period with ipatasertib alone. This will be followed by ipatasertib and rucaparib combination treatment on Cycle 1, Day 1 in the 28 Day Cycle. Patients enrolled in part 1 of the trial will be split into 4 cohorts, each receiving differing dose levels of the study drug: 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. Only patients with advanced prostate cancer will be enrolled in part two of the trial, which is the dose expansion phase. These patients will receive a recommended dose, as advised in part one.

Recruiting Hospitals Read MoreRead more

Cabrini Education and Research Precinct
Malvern
Li Hoon Lai
lihoonlai@cabrini.com.au
(03) 9508 3421

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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