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Prostate CancerPhase 1/2NCT01685268

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

A Phase 1/2 study testing AT13387, abiraterone acetate and Prednisone in people with Prostate Cancer, run by Astex Pharmaceuticals, Inc. at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
AT13387, abiraterone acetate and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
32 sitesin 4 countries
Study dates
Sep 2012to Dec 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

United States20 sites

  • University of Maryland, Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Florida Cancer Specialists-Fort Myers

    Fort Myers, Florida, 33916

  • Clinical Research Alliance, Inc.

    Lake Success, New York, 11042

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • University of California, Los Angeles Institute of Urologic Oncology

    Los Angeles, California, 90024

  • The West Clinic

    Memphis, Tennessee, 38120

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Cancer Center

    Stanford, California, 94305

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Northwest Medical Specialists, PLLC

    Tacoma, Washington, 98405

Other trials in United States

United Kingdom10 sites

  • Brighton & Sussex University Hospitals NHS Trust

    Brighton, BN2 5BE

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Velindre Cancer Center

    Cardiff, CF14 2TL

  • University of Surrey

    Guildford, GU2 7XP

  • Charing Cross Hospital

    London, W6 8RF

  • Royal Marsden Foundation Trust Instute of Cancer Researrch

    London

  • The Christie Hospital NHS Trust

    Manchester, M20 4BX

  • Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, CH63 4JY

  • Nottingham University Hospitals

    Nottingham, NG5 1PB

  • University Hospital Southampton

    Southampton, S016 6YD

Other trials in United Kingdom

Canada1 site

  • Centre hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2L 4MI

Other trials in Canada

Spain1 site

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

Other trials in Spain

About this study

Official title: 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).

Conditions
Prostate Cancer
Being tested
AT13387, abiraterone acetate, Prednisone
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AT13387Drug

    Also called onalespib

    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.

  • abiraterone acetateDrug

    1000 mg PO daily.

  • PrednisoneDrug

    Also called prednisolone

    5 mg PO twice daily.

Study groups in NCT01685268
Study groupRoleWhat they receive
Part A, Regimen 1ExperimentalAT13387 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.
Receives: Drug: AT13387; Drug: abiraterone acetate; Drug: Prednisone
Part A, Regimen 2ExperimentalAt13387 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.
Receives: Drug: AT13387; Drug: abiraterone acetate; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

Secondary outcomes (4)

  1. Pharmacokinetics of combination treatment of AT13387 and abiraterone.

    • 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

    Measured: 24 months

  2. Pharmacodynamics of combination treatment of AT13387 and abiraterone.

    CTC enumeration and characterization every 4 weeks.

    Measured: 24 months

  3. Progression free survival

    Assessment of progression free survival as measured by weeks

    Measured: 24 months

  4. Overall survival

    Overall survival as measured in weeks

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685268
Sponsor's protocol ID
AT13387-04
Status last verified
Aug 2024
First submitted
31 Aug 2012
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AT13387, abiraterone acetate and Prednisone in people with Prostate Cancer, run by Astex Pharmaceuticals, Inc. at 32 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, United Kingdom, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01685268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

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