PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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* To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
* To evaluate PSA (tumor marker) response rate
* To evaluate safety

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Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ARD6562, Docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men with prostate adenocarcinoma with at least one metastatic lesion which is measurable and who progressed after prior hormonal therapy.

Exclusion Criteria

* 1.Body temperature \> 38 degree centigrade.
* 2.Prior radiotherapy to \> 25% of bone marrow.
* 3.Prior isotope therapy and/or brachytherapy
* 4.Prior gene therapy.
* 5.Active double cancer.
* 6.Known brain or leptomeningeal involvement.
* 7.History of hypersensitivity reaction to drug
* 8.Other serious illness or medical condition
* 9.Subjects whom the investigators consider inappropriate from social or medical aspects.

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No