Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

AT13387

+ abiraterone acetate

+ Prednisone

Drug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorAstex Pharmaceuticals, Inc.
Last updated: August 2, 2024
Sourced from a government-validated database.Claim as a partner

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).

Principal SponsorAstex Pharmaceuticals, Inc.
Last updated: August 2, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

49 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
AT13387 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.

Group II

Experimental
At13387 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.

Study 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 Maps

Stanford Cancer Center

Stanford, United States

Holy Cross Hospital

Fort Lauderdale, United States

Florida Cancer Specialists-Fort Myers

Fort Myers, United States
Completed32 Study Centers