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
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: HE3235
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Harbor Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: HE3235
    HE3235 will be administered orally in 28 day cycles.
    Other Name: Apoptone
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716794

Locations
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
Investigators
Study Director: Dwight Stickney, MD Harbor Therapeutics
  More Information

No publications provided

Responsible Party: Nanette Onizuka-Handa/Sr. Vice President, Regulatory Affairs and Quality, Harbor BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT00716794     History of Changes
Other Study ID Numbers: HE3235-0201
Study First Received: July 14, 2008
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Harbor Therapeutics:
Prostate cancer
HE3235
Apoptone

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

ClinicalTrials.gov processed this record on July 20, 2014