NCT00286793

Brief Summary

This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P75+ for phase_1 prostate-cancer

Timeline
Completed

Started Feb 2006

Typical duration for phase_1 prostate-cancer

Geographic Reach
1 country

13 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

February 1, 2006

Completed
2 days 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
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

3.8 years

First QC Date

February 3, 2006

Last Update Submit

June 27, 2011

Conditions

Prostate Cancer

Keywords

at-101at101cancerhormone refractoryprostatedocetaxelprednisone

Outcome Measures

Primary Outcomes (1)

  • Safety of AT-101 in combination with docetaxel and prednisone

    12 months

Secondary Outcomes (1)

  • Preliminary efficacy of AT-101 in combination with docetaxel and prednisone

    12 months

Study Arms (1)

SIngle Arm Study of AT-101 in combination with Docetaxel

EXPERIMENTAL
Drug: AT-101

Interventions

AT-101DRUG

Oral

SIngle Arm Study of AT-101 in combination with Docetaxel

Eligibility Criteria

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

You may qualify if:

  • Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.
  • Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).
  • ECOG performance status 0 or 1
  • Adequate hematologic function
  • Adequate liver and renal function
  • Able to swallow and retain oral medication.
  • Patients enrolled into Cohort B must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising PSA, progression of disease per RECIST, or \>2 new lesions on bone scan.
  • Patients enrolled into Cohort B must have received at least two cycles of docetaxel. Minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
  • At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.

You may not qualify if:

  • Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.
  • Known history of or clinical evidence of central nervous system (CNS) metastases.
  • Active secondary malignancy or history of other malignancy within the last 5 years.
  • Prior history of radiation therapy to \> 25% of the bone marrow
  • Peripheral neuropathy of \> Grade 2
  • Uncontrolled concurrent illness
  • Failure to recover fully, as judged by the investigator, from prior surgical procedures.
  • Concurrent anti-cancer therapy other than docetaxel and prednisone.
  • Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

Fort Meyers, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Fridley, Minnesota, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Wilmington, North Carolina, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Hilton Head Island, South Carolina, United States

Location

Unknown Facility

Germantown, Tennessee, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Richardson, Texas, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Interventions

gossypol acetic acid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lance Leopold, MD

    Ascenta Therapeutics, Inc.

    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

February 3, 2006

First Posted

February 6, 2006

Study Start

February 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

US(13)