NCT00286806

Brief Summary

This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of single-agent AT-101 in men with hormone-refractory prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

4 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

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

1.5 years

First QC Date

February 3, 2006

Last Update Submit

August 20, 2010

Conditions

Hormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events.

Secondary Outcomes (1)

  • Complete or partial remission of disease

Interventions

AT-101DRUG

Eligibility Criteria

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

You may qualify if:

  • Rising PSA, as defined by increasing levels on at least two consecutive assessments
  • ECOG performance status 0 or 1
  • Adequate hematologic function
  • Adequate liver and renal function
  • Able to swallow and retain oral medication.

You may not qualify if:

  • Received prior chemotherapy for HRPC.
  • Concurrent therapy for the treatment of prostate cancer.
  • Clinical signs or symptoms of CNS metastases
  • Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.
  • Active secondary malignancy or history of other malignancy within the last 5 years.
  • Failure to recover from toxicities related to prior therapy.
  • Uncontrolled concurrent illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Greenbrae, California, United States

Location

Unknown Facility

New Haven, Connecticut, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

MeSH Terms

Interventions

gossypol acetic acid

Study Officials

  • Lance Leopold, MD

    Ascenta Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

December 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

US(4)