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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
N/A
Open (Enrolling)
Male
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


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

Type of Study:

Interventional

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:

Yes

Principal Investigator

Johann De Bono, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden Foundation Trust Institute of Cancer Research

Authority:

United States: Food and Drug Administration

Study ID:

AT13387-04

NCT ID:

NCT01685268

Start Date:

September 2012

Completion Date:

January 2015

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Roswell Park Cancer Institute Buffalo, New York  14263
Washington University School of Medicine Saint Louis, Missouri  63110
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Moores UCSD Cancer Center La Jolla, California  92093-0658
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213
Stanford Cancer Center Stanford, California  94305-5824
SUNY Upstate Medical University Syracuse, New York  13210
Holy Cross Hospital Fort Lauderdale, Florida  33308
Cleveland Clinic Cleveland, Ohio  44195
Lakeland Regional Cancer Center Lakeland, Florida  33805
University of Maryland, Greenebaum Cancer Center Baltimore, Maryland  21201
Northwest Medical Specialists, PLLC Tacoma, Washington  98405
The West Clinic Memphis, Tennessee  38120
Center for Cancer & Blood Disorders Bethesda, Maryland  20817
Columbia University Medical Center New York, New York  10032
NYU Clinical Cancer Center New York, New York  10016
Clinical Research Alliance, Inc. Lake Success, New York  11042
University of California, Los Angeles Institute of Urologic Oncology Los Angeles, California  90024
Florida Cancer Specialists-Fort Myers Fort Myers, Florida  33916
MD Anderson-Orlando-Orlando Health Orlando, Florida  32806