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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR