GO27983: 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

Study Status

Open to Enrollment

Study Description

This clinical trial is for men with prostate cancer whose disease worsened while receiving or after receiving treatment with docetaxel.

The purpose of the study is to determine the safety and tolerability of two experimental drugs, GDC-0068 and GDC-0980, when either one is given in combination with the drugs abiraterone and prednisone. The study will also evaluate whether giving GDC-0068 or GDC-0980 with abiraterone improves the efficacy of abiraterone in treating castration-resistant prostate cancer (CRPC).

GDC-0068 is designed to block a protein called Akt, which is thought to be important in cancer. GDC-0980 inhibits a protein called P13-kinase that may be involved in the growth and spread of some cancers. In laboratory experiments, GDC-0068 and GDC-0980 have been shown to prevent or slow the growth of many different types of cancer cells. Abiraterone is FDA-approved for the treatment of CRPC.

Participants at Weill Cornell will participate in the Phase II portion of the study and will be randomly assigned to one of three treatment arms:

  • Arm A: abiraterone/prednisone in combination with GDC-0068
  • Arm B: abiraterone/prednisone in combination with GDC-0980
  • Arm C: abiraterone/prednisone in combination with a placebo (an inactive substance that contains no medicine)

All participants will receive abiraterone, the FDA-approved treatment in combination with prednisone. Abiraterone, prednisone, GDC-0068 and GDC- 0980 are taken by mouth. 

Study participants will continue treatment until their cancer worsens or they experience side effects that cannot be tolerated.

Disease Status and/or Stage

Metastatic or Advanced Prostate Cancer

Sponsor

Genentech

Key Eligibility

  • Age 18 and older
  • Metastatic or advanced prostate cancer
  • Previously treated with docetaxel and progressed during treatment of at least one hormonal therapy
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Scott Tagawa, MD

Contact

Protocol ID

GO27983

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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