A Randomized Phase 2 Study of Human Anti-PDGRFa Monoclonal Antibody IMC-3G3 plus Mitoxantrone plus Prednisone or Mitoxantrone plus Prednisone in Metastatic Castration-Refractory Prostate Cancer (CRPC) Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy. - ND

• Conditions: Metastatic Castration Refractory Prostate Cancer; MedDRA version: 12.1Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastatic

• Registration Number: EUCTR2009-018015-11-IT
• Lead Sponsor: IMCLONE LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-05
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. The patient has histologically-confirmed adenocarcinoma of the prostate. 2. The patient has radiographic evidence of metastatic prostate cancer (stage M1 or D2). 3. The patient has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of < 50 ng/mL (castration-refractory). If the method of castration is luteinizing hormone releasing hormone (LHRH) agonists, the patient must be willing to continue the use of LHRH agonists during protocol treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The patient has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms. A patient with previous history of malignancy is eligible provided that there has been no evidence of disease recurrence during the prior 3 years. 2. The patient has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease. (Patients who have had a treatment break followed by a second docetaxel-based regimen with subsequent disease progression are eligible.) 3. The patient has received prior therapy with mitoxantrone for advanced prostate cancer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified