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A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate
Not Recruiting
Trial ID: NCT01685268
Purpose
A 2-part, Phase 1-2, open-label, parallel group, randomized study in patients with
Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with
abiraterone and steroids. In Part A (Phase 1), patients will continue to receive the same
doses of abiraterone and steroids they were receiving prior to study entry and will be
randomized to receive 1 of 2 different treatment regimens of AT13387 in combination with
abiraterone. Once the best regimen is established in Part A, based on safety and antitumor
activity, patients will be randomized to the selected treatment regimen and dose of AT13387
in combination with abiraterone or AT13387 alone in Part B (Phase 2).
Official Title
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
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
Inclusion:
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
Exclusion:
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
drug
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
Intervention(s):
drug: AT13387
drug: abiraterone acetate
drug: Prednisone
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061