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

NCT04404140 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-10-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2022-10-14
Completion
2022-10-14
FDA Drug
Yes

Countries

  • France
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04404140 on ClinicalTrials.gov