A Phase I/II Study of HE3235 in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716794
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : March 9, 2011
Information provided by:
Harbor Therapeutics

July 14, 2008
July 16, 2008
March 9, 2011
July 2008
March 2011   (Final data collection date for primary outcome measure)
  • To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles. [ Time Frame: Treatment period ]
  • To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing. [ Time Frame: Treatment period ]
  • To assess potential activity of HE3235 in prostate cancer patients. [ Time Frame: Treatment period and post-study follow-up period ]
Same as current
Complete list of historical versions of study NCT00716794 on Archive Site
  • Explore circulating tumor cell (CTC) enumeration in response to treatment as a marker evaluating whether an investigational therapy is effective for tumor treatment [ Time Frame: Treatment period ]
  • Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response. [ Time Frame: Treament period and post-study follow-up ]
Same as current
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A Phase I/II Study of HE3235 in Patients With Prostate Cancer
A Phase I/II, Open-Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Activity of HE3235 When Administered Orally to Patients With Prostate Cancer
This is a phase I/II, open-label, dose escalation study of HE3235 administered orally to patients with advanced prostate cancer who have failed hormone therapy and at least one taxane based chemotherapy regimen.
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: HE3235
HE3235 will be administered orally in 28 day cycles.
Other Name: Apoptone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2011
March 2011   (Final data collection date for primary outcome measure)

Main Inclusion Criteria:

  • Patient is male and at least 18 years of age, at the time of screening;
  • Patient has metastatic disease (any T, any N, M1);
  • Patient has failed at least 1 taxane regimen; or Patient has symptomatic or asymptomatic CRPC and is chemotherapy-naïve
  • Patient has histologically or cytologically confirmed adenocarcinoma of the prostate;
  • Patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following:

    • PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart.
    • Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria;
    • Progression of metastatic bone disease on bone scan with > 2 new lesions
  • Patient has ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;

Main Exclusion Criteria:

  • Patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation Treated epidural disease is allowed
  • Patient has active infection;
  • Patient having a history of clinically significant cardiovascular disease (such as CHF), clinically significant hepatic, respiratory or renal abnormalities;
  • Patient who has any clinically significant abnormalities in laboratory results at screening
  • Patient who has a history of clinically significant neurological or psychiatric condition;

Additional criteria are applicable to expansion cohorts.

Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Nanette Onizuka-Handa/Sr. Vice President, Regulatory Affairs and Quality, Harbor BioSciences, Inc.
Harbor Therapeutics
Not Provided
Study Director: Dwight Stickney, MD Harbor Therapeutics
Harbor Therapeutics
March 2011

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