Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Prostate Cancer
In brief
This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.
Key facts
- Study ID
- NCT01485861
- Run by
- Genentech, Inc.
- People needed
- 298
- Starts
- 2012-01-11
- Expected to finish
- 2022-08-31
- Last updated by the study team
- 2023-09-14
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy(prior docetaxel is not required for the safety cohort)
- Two rising PSA levels greater than or equal to (>/=) 2 ng/mL measured >/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
- Adequate hematologic and organ function
- Documented willingness to use an effective means of contraception
- Safety cohort only: agreement to use CGM for first cycle of treatment
You may not qualify if…
- History of Type I or Type II diabetes mellitus requiring insulin; safety cohort: patients who are receiving any pharmacologic treatment for diabetes are not eligible
- New York Heart Association Class III or IV heart failure or Left ventricular ejection fraction < 50% or ventricular arrhythmia requiring medication
- Significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident within 6 months prior to Day 1
- Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy
- Clinically significant history of liver disease
- History of adrenal insufficiency or hyperaldosteronism
- Phase II only: Previous therapy for prostate cancer with 17 alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone
- Phase II only: Previous treatment for prostate cancer with Protein kinase B phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors
- Need for chronic corticosteroid therapy of >/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
Where it is running
- Pacific Hematology Oncology Associates — San Francisco, California, United States
- Florida Cancer Specialists - Fort Myers (New Hampshire Ct) — Fort Myers, Florida, United States
- Florida Cancer Specialists; Sarasota — Sarasota, Florida, United States
- Kaiser Permanente Medical Ctr — Honolulu, Hawaii, United States
- Johns Hopkins Univ; Bunting Blaustein Cancer Center — Baltimore, Maryland, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Urology Cancer Center & GU Research Network — Omaha, Nebraska, United States
- New York Cancer and Blood Specialists - Setauket Medical Oncology — East Setauket, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
- Sarah Cannon Cancer Center - Tennessee Oncology, Pllc — Nashville, Tennessee, United States
- Masarykuv onkologicky ustav — Brno, Czechia
- Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie — Hradec Králové, Czechia
- Urocentrum Praha s.r.o. — Prague, Czechia
- Vseobecna fakultni nemocnice v Praze — Prague, Czechia
- Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni — Prague, Czechia
- ICO Paul Papin; Oncologie Medicale. — Angers, France
- Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes — Lyon, France
- Hia Du Val De Grace — Paris, France
- Institut Curie; Oncologie Medicale — Paris, France
- GH Paris Saint Joseph; Hopital De Jour Oncologie — Paris, France
- Hopital d'Instruction des Armees de Begin — Saint-Mandé, France
- Institut Gustave Roussy; Departement Oncologie Medicale — Villejuif, France
- Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine — Athens, Greece
- HonorHealth Research Institute ? Bisgrove — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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