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

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Trial Identification

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

Official Title: 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.

Study ID: NCT04404140

Study Description

Brief 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

HOPITAL JEAN MINJOZ; Oncologie, Besancon, , France

Centre Val Aurelle Paul Lamarque; Radiotherapie, Montpellier, , France

Hopital d'Instruction des Armees de Begin, Saint-Mande, , France

Gustave Roussy, Villejuif, , France

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, 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, Zürich, , Switzerland

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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