A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate
1 other identifier
interventional
49
4 countries
32
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started Sep 2012
Shorter than P25 for phase_1 prostate-cancer
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 2, 2024
August 1, 2024
1.8 years
August 31, 2012
August 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
* 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
12 months
Part B: Compare the antitumor activity (response rate per the Prostate Cancer Working Group 2 [PCWG2]) between single-agent AT13387 and combination of AT13387 plus abiraterone in patients who are no longer responding to treatment with abiraterone alone.
* 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
12 months
Secondary Outcomes (4)
Pharmacokinetics of combination treatment of AT13387 and abiraterone.
24 months
Pharmacodynamics of combination treatment of AT13387 and abiraterone.
24 months
Progression free survival
24 months
Overall survival
24 months
Study Arms (2)
Part A, Regimen 1
EXPERIMENTALAT13387 given as a 1-hr IV infusion at a starting dose of 220 mg/m2 once weekly for 3 weeks in a 4-week cycle, in combination with abiraterone acetate 1000 mg by mouth (PO) daily (QD) and prednisone or prednisolone 5 mg PO twice daily.
Part A, Regimen 2
EXPERIMENTALAt13387 administered as a 1-hr IV infusion at a starting dose of 120 mg/m2 on Day 1 and Day 2 weekly for 3 weeks in a 4-week cycle, in combination with abiraterone acetate 1000 mg by mouth (PO) daily (QD) and prednisone or prednisolone 5 mg PO twice daily.
Interventions
Regimen 1: AT13387, given as 1-hr intravenous infusion at starting dose of 220 mg/m2 once weekly for 3 weeks in a 4-week cycle. Regimen 2: AT13387, given as 1-hr IV infusion at starting dose of 120 mg/m2 on Day 1 and Day 2 weekly for 3 weeks in a 4-week cycle.
Eligibility Criteria
You may qualify if:
- Must have prostate cancer
- Have received prior castration by orchiectomy and/or hormone therapy
- Males \>18 years of age
- Normal activity level for self care
- Have been receiving abiraterone therapy with a steroid for ≥1 month
- Have disease progression on abiraterone as defined by either PSA progression, radiographic or bone progression
- Have adequate bone marrow, liver and kidney function
- 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
- Must be willing and able to provide written informed consent and comply with the protocol and study procedures
You may not qualify if:
- Prior anti-cancer treatment with any Heat Shock Protein 90 (HSP90) inhibitor or histone deacetylase (HDAC) inhibitor compound
- Have received chemotherapy within 4 weeks prior to receiving study drug
- Prior prostate surgery or radiotherapy within 4 weeks from the first dose of study drug
- Hypersensitivity to AT13387 or other components of the drug product
- Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
- Severe systemic diseases or active uncontrolled infections
- Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
- Abnormal heart function
- 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;
- No known brain or CNS involvement
- Unable to receive corticosteroids or history of pituitary or adrenal dysfunction
- Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
University of California, Los Angeles Institute of Urologic Oncology
Los Angeles, California, 90024, United States
Stanford Cancer Center
Stanford, California, 94305, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists-Fort Myers
Fort Myers, Florida, 33916, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Clinical Research Alliance, Inc.
Lake Success, New York, 11042, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Northwest Medical Specialists, PLLC
Tacoma, Washington, 98405, United States
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2L 4MI, Canada
Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Brighton & Sussex University Hospitals NHS Trust
Brighton, BN2 5BE, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Velindre Cancer Center
Cardiff, CF14 2TL, United Kingdom
University of Surrey
Guildford, GU2 7XP, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Royal Marsden Foundation Trust Instute of Cancer Researrch
London, United Kingdom
The Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Nottingham University Hospitals
Nottingham, NG5 1PB, United Kingdom
University Hospital Southampton
Southampton, S016 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2012
First Posted
September 14, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2014
Study Completion
December 1, 2014
Last Updated
August 2, 2024
Record last verified: 2024-08