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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: HE3235 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • Drug: HE3235
    HE3235 will be administered orally in 28 day cycles.
    Other Name: Apoptone

Primary Outcome Measures :
  1. To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles. [ Time Frame: Treatment period ]
  2. To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing. [ Time Frame: Treatment period ]
  3. To assess potential activity of HE3235 in prostate cancer patients. [ Time Frame: Treatment period and post-study follow-up period ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716794

United States, Arizona
Scottsdale, Arizona, United States, 85260
United States, California
Encinitas, California, United States, 92024
Roseville, California, United States, 95661
San Francisco, California, United States, 94115
United States, New York
New York, New York, United States, 10065
United States, North Carolina
Charlotte, North Carolina, United States, 28204
United States, Texas
San Antonio, Texas, United States, 78229
United States, Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Harbor Therapeutics
Study Director: Dwight Stickney, MD Harbor Therapeutics

Responsible Party: Nanette Onizuka-Handa/Sr. Vice President, Regulatory Affairs and Quality, Harbor BioSciences, Inc. Identifier: NCT00716794     History of Changes
Other Study ID Numbers: HE3235-0201
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: March 9, 2011
Last Verified: March 2011

Keywords provided by Harbor Therapeutics:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases