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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01685268
First received: August 31, 2012
Last updated: May 8, 2014
Last verified: May 2014

August 31, 2012
May 8, 2014
September 2012
September 2014   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
    • 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
  • 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 ] [ Designated as safety issue: No ]
    • 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
Same as current
Complete list of historical versions of study NCT01685268 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of combination treatment of AT13387 and abiraterone. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    • 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
  • Pharmacodynamics of combination treatment of AT13387 and abiraterone. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    CTC enumeration and characterization every 4 weeks.
  • Progression free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessment of progression free survival as measured by weeks
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Overall survival as measured in weeks
Same as current
Not Provided
Not Provided
 
A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate
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).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: AT13387 and abiraterone
    Parallel
    Other Name: AT13387 and Zytiga
  • Drug: AT13387 alone
    Parallel
    Other Name: AT13387
  • Experimental: AT13387 and abiraterone
    Part A: AT13387 IV with abiraterone 1000 mg QD and prednisone or prednisolone 5 mg BID
    Intervention: Drug: AT13387 and abiraterone
  • Experimental: AT13387 alone or in combination with abiraterone acetate
    Part B: AT13387 alone or AT13387 with abiraterone acetate 1000 mg PO
    Intervention: Drug: AT13387 alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
164
January 2015
September 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Spain,   United Kingdom
 
NCT01685268
AT13387-04
No
Astex Pharmaceuticals
Astex Pharmaceuticals
Not Provided
Principal Investigator: Johann De Bono, MD Royal Marsden Foundation Trust Institute of Cancer Research
Astex Pharmaceuticals
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP