NCT04404140

A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).

A Phase Ib, Open-Label, Multicenter Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study evaluating the safety, preliminary efficacy and pharmacokinetics of ipatasertib in combination with atezolizumab and docetaxel in participants with mCRPC previously treated with second-generation AR (Androgen Receptor)-targeted therapy. The study consists of two parts: \[1\] Part A: Safety run-in cohort of approximately 12 participants; \[2\] Part B: Expansion cohort of approximately 38 participants. All participants in this study will continue to be treated until progression of disease, loss of clinical benefit, unacceptable toxicity or withdrawal of consent.

Conditions

• Castration-Resistant Prostatic Cancer

Interventions

Type	Name	Description
DRUG	Ipatasertib	Ipatasertib will be administered at a dose of 400 mg, as per the dosing schedule described above.
DRUG	Atezolizumab	Atezolizumab will be administered at a fixed dose of 1200 mg, as per the dosing schedule described above.
DRUG	Docetaxel	Docetaxel will be administered at a dose of 75 mg/m\^2, as per the dosing schedule described above.

Timeline

• Start date: 2020-07-09
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2020-05-27
• Last updated: 2023-10-17

Locations

9 sites across 4 countries: France, Italy, Spain, Switzerland

Regulatory

• FDA-regulated drug study