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
AT13387
+ abiraterone acetate
+ Prednisone
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.49 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion: 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 Exclusion: 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 32 locations
University of California, Los Angeles Institute of Urologic Oncology
Los Angeles, United StatesOpen University of California, Los Angeles Institute of Urologic Oncology in Google MapsStanford Cancer Center
Stanford, United StatesHoly Cross Hospital
Fort Lauderdale, United StatesFlorida Cancer Specialists-Fort Myers
Fort Myers, United States