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A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone

Phase 1/Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone

Inclusion Criteria


1. Must have prostate cancer

2. Have received prior castration by orchiectomy and/or hormone therapy

3. Males >18 years of age

4. Normal activity level for self care

5. Have been receiving abiraterone therapy with a steroid for ≥1 month

6. Have disease progression on abiraterone as defined by either PSA progression,
radiographic or bone progression

7. Have adequate bone marrow, liver and kidney function

8. Must be willing to provide pre-existing tumor samples, if this material exists. If
pre-existing samples are not available, a sample must be obtained during screening

9. Must be willing and able to provide written informed consent and comply with the
protocol and study procedures


1. Prior anti-cancer treatment with any Heat Shock Protein 90 (HSP90) inhibitor or
histone deacetylase (HDAC) inhibitor compound

2. Have received chemotherapy within 4 weeks prior to receiving study drug

3. Prior prostate surgery or radiotherapy within 4 weeks from the first dose of study

4. Hypersensitivity to AT13387 or other components of the drug product

5. Treatment with any investigational drug within 4 weeks prior to the first dose of
study drug

6. Severe systemic diseases or active uncontrolled infections

7. Presence of a life-threatening illness, medical condition, organ system dysfunction,
or other factors

8. Abnormal heart function

9. Other cancer except for adequately treated basal cell or squamous cell carcinoma of
the skin, or superficial bladder cancer, or other cancer from which the subject has
been disease-free for at least 3 years;

10. No known brain or CNS involvement

11. Unable to receive corticosteroids or history of pituitary or adrenal dysfunction

12. Known history of human immunodeficiency virus (HIV) or seropositive test for
hepatitis C virus or hepatitis B virus

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part A: Safety and tolerability of the combination of AT13387 and abiraterone and to select the most promising treatment regimen in CRPC patients who are no longer responding to treatment with abiraterone alone.

Outcome Description:

Number of patients with adverse events Change in prostate specific antigen measurement and circulating tumor cell count every 4 weeks Change in tumor measurements by RECIST 1.1 every 12 weeks

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Johann De Bono, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden Foundation Trust Institute of Cancer Research


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

January 2015

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms



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