Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Coralie in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:January 11, 2012
End Date:July 31, 2019

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A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

This multicenter, international, Phase Ib/II trial consists of two stages: a Phase Ib,
open-label stage in which the recommended Phase II dose will be determined for ipatasertib
and apitolisib in combination with abiraterone and prednisone/prednisolone and a Phase II,
3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and
prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone.


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

- 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

Exclusion Criteria:

- History of Type I or Type II diabetes mellitus requiring insulin

- 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
We found this trial at
13
sites
823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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1650 Orleans Street
Baltimore, Maryland 21231
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Brno,
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Detroit, Michigan 48201
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235 North Belle Mead Avenue
East Setauket, New York 11733
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15681 New Hampshire Court
Fort Myers, Florida 33901
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Honolulu, Hawaii 96819
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New York, New York 10021
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Saint Petersburg, Florida 33705
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San Francisco, California 94115
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Sarasota, Florida 34232
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Scottsdale, Arizona 85258
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