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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Drug: ARD6562, Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00291005

XRP6976J/2101

ARD6562

Details and patient eligibility

About

• 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

Sex: Male

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)