A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate
Status: | Completed |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2012 |
End Date: | December 2014 |
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
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 continued to receive the same doses
of abiraterone and steroids they were receiving prior to study entry and were randomized to
receive 1 of 2 different treatment regimens of AT13387 in combination with abiraterone. Once
the best regimen was established in Part A, based on safety and antitumor activity, patients
were to be randomized to the selected treatment regimen and dose of AT13387 in combination
with abiraterone or AT13387 alone in Part B (Phase 2).
Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with
abiraterone and steroids. In Part A (Phase 1), patients continued to receive the same doses
of abiraterone and steroids they were receiving prior to study entry and were randomized to
receive 1 of 2 different treatment regimens of AT13387 in combination with abiraterone. Once
the best regimen was established in Part A, based on safety and antitumor activity, patients
were to be randomized to the selected treatment regimen and dose of AT13387 in combination
with abiraterone or AT13387 alone in Part B (Phase 2).
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
We found this trial at
21
sites
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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801 N Rutledge St
Springfield, Illinois 62702
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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