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A Study Comparing AT-101 in Combination With Docetaxel and Prednisone Versus Docetaxel and Prednisone in Men With Chemotherapy-Naïve Metastatic Hormone Refractory Prostate Cancer (HRPC)

NCT00571675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2010-11-09

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, multinational Phase 2 study to evaluate and compare oral AT-101 in combination with docetaxel and prednisone versus docetaxel and prednisone plus placebo in the treatment of chemotherapy-naïve metastatic hormone-refractory prostate cancer, who have received hormonal therapy but not chemotherapy.

Conditions

  • Hormone Refractory Prostate Cancer

Interventions

DRUG

AT-101, prednisone and docetaxel

docetaxel (75mg/m2 intravenously over 1 hour on day 1, every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral AT-101 on cycle days 1-3

DRUG

placebo, prednisone and docetaxel

docetaxel (75mg/m2 intravenously over 1 hour every 21 days \[one cycle\]), oral prednisone (5mg BID on days 1-21), and oral placebo on cycle days 1-3

Sponsors & Collaborators

  • Ascenta Therapeutics

    lead INDUSTRY

Principal Investigators

  • Lance Leopold, MD · Ascenta Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00571675 on ClinicalTrials.gov