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Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

An Open Label, Randomized, Phase II Study of AS1404 in Combination With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

NCT00111618•Antisoma Research

View on ClinicalTrials.gov

Summary

The purpose of this trial is to confirm a safe dose of AS1404, to be given with docetaxel, and to see whether adding AS1404 and docetaxel together improves the outcome of the treatment, when compared to docetaxel alone.

Detailed Description

The overall aim of this study is to determine the safety, tolerability and efficacy of AS1404 in combination with docetaxel in patients with hormone refractory metastatic prostate cancer.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Age equal to, or greater than 18 years
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Life expectancy greater than or equal to 3 months
•Histopathologically confirmed adenocarcinoma of the prostate
•Metastatic progressive androgen-independent prostate cancer with no previous chemotherapy treatment
•At least 4 weeks off of flutamide and 6 weeks off of bicalutamide and nilutamide
•Patients who have not undergone surgical castration must continue treatment with an luteinizing hormone-releasing hormone (LHRH) agonist. In those patients where, for some reason, the LHRH agonist has been discontinued prior to entry on the study, it should be reinstituted and disease progression must be documented.
•Hematological and biochemical indices at screening within the following ranges:
•* An absolute neutrophil count of greater than or equal to 1.5 x 10\^9/L;
•* A platelet count of greater than or equal to 100 x 10\^9/L;
+7 more criteria

Exclusion Criteria

•Decreasing PSA levels after antiandrogen withdrawal
•Previous chemotherapy treatment for prostate cancer
•Patients who have received blood transfusions or growth factors to aid hematological recovery within two weeks of scheduled baseline visit
•Concurrent severe and/or uncontrolled co-morbid medical condition within 2 weeks of screening
•Previous exposure to AS1404 or other vascular targeting agents
•Clinically significant cardiac arrhythmias and known QTc prolongation (interval \>450 msec)
•Evidence of severe or uncontrolled systemic disease that, in the opinion of the Investigator, might interfere with the patient's participation in the study
•A history of alcoholism; drug addiction; or any psychiatric condition, which, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures
•A history of hypersensitivity to taxanes or other drugs formulated with polysorbate 80
•Treatment with the following medications within two weeks of AS1404 administration or the expected need for such treatments during the study period:
+9 more criteria

Locations (27)

Central Hematology Oncology Medical Group Inc

Alhambra, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Providence Saint Joseph's Medical Center (PSJMC)

Burbank, California, United States

Pacific Oncology & Hematology Associates

Encinitas, California, United States

Virginia K. Crosson Cancer Center

Fullerton, California, United States

Pacific Shores Medical Group

Long Beach, California, United States

UCLA Clinical Research Unit

Los Angeles, California, United States

North Valley Hematology/Oncology Medical Group, The Thomas and Dorothy Leavey Cancer Center

Northridge, California, United States

Ventura County Hematology-Oncology Specialists

Oxnard, California, United States

Cancer Care Associates Medical Group, Inc

Redondo Beach, California, United States

Key Dates

Start Date

May 1, 2005

Primary Completion Date

June 1, 2007

Completion Date

August 1, 2008

Last Updated

January 30, 2009

Enrollment

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

AS1404 (DMXAA)

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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