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
235 North Belle Mead Avenue
East Setauket, New York 11733
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East Setauket, NY
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1650 Orleans Street
Baltimore, Maryland 21231
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Baltimore, MD
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Brno,
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Detroit, Michigan 48201
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Detroit, MI
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15681 New Hampshire Court
Fort Myers, Florida 33901
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Fort Myers, FL
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Honolulu, Hawaii 96819
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Honolulu, HI
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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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Myrtle Beach, SC
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Nashville, TN
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New York, New York 10021
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New York, NY
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Saint Petersburg, Florida 33705
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Saint Petersburg, FL
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San Francisco, California 94115
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San Francisco, CA
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Sarasota, Florida 34232
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Sarasota, FL
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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