Prostate Cancer Clinical Trial
Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
Summary
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in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 59 Locations for this study
Scottsdale Arizona, 85258, United States
San Francisco California, 94115, United States
Fort Myers Florida, 33901, United States
Sarasota Florida, 34232, United States
Honolulu Hawaii, 96819, United States
Baltimore Maryland, 21231, United States
Detroit Michigan, 48201, United States
Omaha Nebraska, 68130, United States
East Setauket New York, 11733, United States
New York New York, 10065, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37203, United States
Brno , 656 5, Czechia
Hradec Kralove , 50012, Czechia
Praha 2 , 120 0, Czechia
Praha 2 , 128 0, Czechia
Praha , 140 5, Czechia
Angers , 49055, France
Lyon , 69008, France
Paris , 75230, France
Paris , 75231, France
Paris , 75674, France
Saint-Mande , 94160, France
Villejuif , 94805, France
Athens , 115 2, Greece
Heraklion , 711 1, Greece
Patras , 265 0, Greece
Piraeus , 185 4, Greece
ΛαÏισα , 413 3, Greece
Meldola Emilia-Romagna, 47014, Italy
Cremona Lombardia, 26100, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Arezzo Toscana, 52100, Italy
Amsterdam , 1066 , Netherlands
Amsterdam , 1081 , Netherlands
Den Haag , 2512 , Netherlands
Nijmegen , 6525 , Netherlands
Rotterdam , 3045 , Netherlands
Brasov , 50001, Romania
Bucharest , 05065, Romania
Cluj Napoca , 40001, Romania
Timisoara , 30023, Romania
Turda , 40110, Romania
Elche Alicante, 03203, Spain
Badalona Barcelona, 08916, Spain
Sabadell Barcelona, 8208, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
Birmingham , B15 2, United Kingdom
Glasgow , G12 0, United Kingdom
Leeds , LS9 7, United Kingdom
Liverpool , L7 8Y, United Kingdom
London , W1G 6, United Kingdom
Sutton , SM2 5, United Kingdom
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