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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). | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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.

NCT04404140•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Ability to comply with the study protocol.
•Adenocarcinoma of the prostate without small-cell or neuroendocrine features.
•Metastatic disease that cannot be treated with curative intent.
•Surgical or medical castration with testosterone serum level \< 50 ng/dL (1.7 nM).
•For participants treated with luteinizing hormone-releasing hormone analogs, initiation therapy \>= 4 weeks prior to the first dose of study treatment and continued therapy throughout study treatment.
•Progression of Prostate Cancer.
•Receipt of at least one prior line of second generation AR-targeted therapy.
•For participants in Part A of study: measurable visceral disease or measurable extrapelvic adenopathy per RECIST v1.1.
•For participants in Part B of study: either measurable visceral disease or measurable extrapelvic adenopathy by RECIST v1.1 or bone lesions by bone scan, or both.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
+5 more criteria

Exclusion Criteria

•Prior treatment with an AKT, PI3K, or mTOR inhibitor.
•Prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer.
•Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
•Prior treatment with docetaxel or another chemotherapy agent for mCRPC.
•Treatment with investigational therapy within 14 days prior to initiation of study drug.
•History or known presence of central nervous system metastases including leptomeningeal carcinomatosis.
•Uncontrolled tumor-related pain.
•Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment.
•Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco- regional therapy if appropriate prior to enrollment.
•Non-study-related minor surgical procedures =\< 5 days or major (invasive) surgical procedure =\< 28 days prior to the first dose of study treatment.
+25 more criteria

Locations (9)

HOPITAL JEAN MINJOZ; Oncologie

Besançon, France

Centre Val Aurelle Paul Lamarque; Radiotherapie

Montpellier, France

Hopital d'Instruction des Armees de Begin

Saint-Mandé, France

Gustave Roussy

Villejuif, France

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, Spain

Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

Chur, Switzerland

UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

Zurich, Switzerland

Key Dates

Start Date

July 9, 2020

Primary Completion Date

October 14, 2022

Completion Date

October 14, 2022

Last Updated

October 17, 2023

Enrollment

ACTUAL participants

Conditions

Castration-Resistant Prostatic Cancer

Interventions

Ipatasertib

DRUG

Atezolizumab

DRUG

Docetaxel

DRUG

The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma

NCT04104607

Castration-Resistant Prostatic Cancer

View study

TEMPORARILY_NOT_AVAILABLE

Expanded Access Treatment with [Lu-177]-PNT2002 for Adult Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06033001

Castration-Resistant Prostatic Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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