A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate

August 1, 2024 updated by: Astex Pharmaceuticals, Inc.

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 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4MI
        • Centre Hospitalier de l'Université de Montréal (CHUM)
  • Spain
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • Brighton & Sussex University Hospitals NHS Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Center
      • Guildford, United Kingdom, GU2 7XP
        • University of Surrey
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, United Kingdom
        • Royal Marsden Foundation Trust Instute of Cancer Researrch
      • Manchester, United Kingdom, M20 4BX
        • The Christie Hospital NHS Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals
      • Southampton, United Kingdom, S016 6YD
        • University Hospital Southampton
      • Wirral, United Kingdom, CH63 4JY
        • Clatterbridge Cancer Centre NHS Foundation Trust
  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University of California, Los Angeles Institute of Urologic Oncology
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists-Fort Myers
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Cancer Center
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer & Blood Disorders
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Lake Success, New York, United States, 11042
        • Clinical Research Alliance, Inc.
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialists, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A, Regimen 1
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.
Drug: AT13387
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.
Other Names:
  • onalespib
Drug: abiraterone acetate
1000 mg PO daily.
Drug: Prednisone
5 mg PO twice daily.
Other Names:
  • prednisolone
Experimental: Part A, Regimen 2
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.
Drug: AT13387
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.
Other Names:
  • onalespib
Drug: abiraterone acetate
1000 mg PO daily.
Drug: Prednisone
5 mg PO twice daily.
Other Names:
  • prednisolone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
  • 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.
Time Frame: 12 months
  • 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of combination treatment of AT13387 and abiraterone.
Time Frame: 24 months
  • Area under the plasma concentration versus time curve (AUC) of AT13387 and abiraterone alone and in combination by Week 4
  • Maximum concentration (Cmax) of AT13387 and abiraterone alone and in combination by Week 4
24 months
Pharmacodynamics of combination treatment of AT13387 and abiraterone.
Time Frame: 24 months
CTC enumeration and characterization every 4 weeks.
24 months
Progression free survival
Time Frame: 24 months
Assessment of progression free survival as measured by weeks
24 months
Overall survival
Time Frame: 24 months
Overall survival as measured in weeks
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astex Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Johann De Bono, MD, Royal Marsden Foundation Trust Institute of Cancer Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT13387-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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