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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: HE3235

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
  • California
    • Encinitas, California, United States, 92024
    • Roseville, California, United States, 95661
    • San Francisco, California, United States, 94115
  • New York
    • New York, New York, United States, 10065
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
  • Texas
    • San Antonio, Texas, United States, 78229
  • Washington
    • Seattle, Washington, United States, 98109

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Explore circulating tumor cell (CTC) enumeration in response to treatment as a marker evaluating whether an investigational therapy is effective for tumor treatment	Treatment period
Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response.	Treament period and post-study follow-up

Collaborators and Investigators

• Sponsor: Harbor Therapeutics
• Investigators: Study Director: Dwight Stickney, MD, Harbor Therapeutics

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Estimate): March 9, 2011
• Last Update Submitted That Met QC Criteria: March 8, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Prostate cancer; HE3235; Apoptone
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HE3235-0201