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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


Inclusion Criteria:



- Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been
previously treated with docetaxel and has progressed during treatment of at least one
hormonal therapy

- Two rising PSA levels >/= 2 ng/mL measured >/= 1 week apart or radiographic evidence
of disease progression in soft tissue or bone

- ECOG performance status of 0, 1, or 2

- 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

- NYHA Class III or IV heart failure or LVEF < 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 CYP17 inhibitors, including
abiraterone

- Phase II only: Previous treatment for prostate cancer with Akt, PI3K, and/or mTOR
inhibitors

- Need for chronic corticosteroid therapy of >/= 20 mg of prednisone per day or an
equivalent dose of other anti inflammatory corticosteroids or immunosuppressant

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Incidence of dose-limiting toxicity (DLTs) for Phase Ib

Outcome Time Frame:

up to 28 days

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GO27983

NCT ID:

NCT01485861

Start Date:

December 2011

Completion Date:

January 2016

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Nashville, Tennessee  37203-1632
Flint, Michigan  48532
Omaha, Nebraska  68114
Boston, Massachusetts  
Charleston, South Carolina  
Honolulu, Hawaii  96813