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

Sponsor
Hoffmann-La Roche
Study ID
NCT04404140
Phase
PHASE1
Status
Terminated

Conditions

  • Castration-Resistant Prostatic Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 9, 2020
Status verified
Oct 2023
Primary completion
Oct 14, 2022
Completion
Oct 14, 2022

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipatasertib + Atezolizumab + Docetaxel
    Part A (Safety Run-In): 12 Participants will be administered Ipatasertib orally once a day \[QD\] from Day 1 to Day 14 in combination with Atezolizumab administered by intravenous (IV infusion) every 3 weeks (Q3W) on Day 1 of each cycle (a cycle being 21 days) and Docetaxel administered by IV infusion (Q3W) on Day 1 of each cycle. Docetaxel will be administered for a maximum of 10 cycles (approximately 7 months), after which Atezolizumab and Ipatasertib will be administered as a doublet until disease progression. During Part A, a staggered recruitment will be applied to the first and potentially first 6 participants to enrol a participant only once the former one has safely overcome the safety time window (Cycle 1). Part B (Expansion): 38 Participants will be administered Ipatasertib, Atezolizumab and Docetaxel as described above, though without a staggered enrolment or safety assessment window.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 35 months ]

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