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

This study has been completed.
Sponsor:
Information provided by:
Harbor Therapeutics
ClinicalTrials.gov Identifier:
NCT00716794
First received: July 14, 2008
Last updated: March 8, 2011
Last verified: March 2011

July 14, 2008
March 8, 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing. [ Time Frame: Treatment period ] [ Designated as safety issue: No ]
  • To assess potential activity of HE3235 in prostate cancer patients. [ Time Frame: Treatment period and post-study follow-up period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00716794 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: HE3235
HE3235 will be administered orally in 28 day cycles.
Other Name: Apoptone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
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.

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00716794
HE3235-0201
No
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