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

NCT ID: NCT00716794

Last Updated: 2011-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-03-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

HE3235

HE3235 will be administered orally in 28 day cycles.

Intervention Type: DRUG

Other Intervention Names

Apoptone

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Harbor Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Harbor BioSciences, Inc.

Principal Investigators

Dwight Stickney, MD

Role: STUDY_DIRECTOR

Harbor Therapeutics

Locations

Scottsdale, Arizona, United States

Encinitas, California, United States

Roseville, California, United States

San Francisco, California, United States

New York, New York, United States

Charlotte, North Carolina, United States

San Antonio, Texas, United States

Seattle, Washington, United States

Countries

United States

Other Identifiers

HE3235-0201

Identifier Type: -

Identifier Source: org_study_id