NCT00716794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 9, 2011

Status Verified

March 1, 2011

Enrollment Period

2.7 years

First QC Date

July 14, 2008

Last Update Submit

March 8, 2011

Conditions

Prostate Cancer

Keywords

Prostate cancerHE3235Apoptone

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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

Interventions

HE3235DRUG

HE3235 will be administered orally in 28 day cycles.

Also known as: Apoptone

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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-naìˆve
  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Scottsdale, Arizona, 85260, United States

Location

Unknown Facility

Encinitas, California, 92024, United States

Location

Unknown Facility

Roseville, California, 95661, United States

Location

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Charlotte, North Carolina, 28204, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

17-ethynylandrostane-3,17-diol

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Dwight Stickney, MD

    Harbor Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 9, 2011

Record last verified: 2011-03

Locations

US(8)