Randomized Phase 2 study of the human monoclonal antibody IMC-3G3 plus a typically used chemotherapy regimen of Mitoxantrone plus Prednisone or the respective chemotherapy regimen alone in patients with prostate cancer that do no longer respond to or showed unbearable toxicity of docetaxel chemotherapy.

Phase 1

• Conditions: Metastatic Castration-Refractory Prostate Cancer; MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-018015-11-BE
• Lead Sponsor: ImClone LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-19
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

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

Inclusion Criteria

- Histologically-confirmed adenocarcinoma of the prostate
- castration resistant
- progression after or toxicity of docetaxel
- adequate hematologic, hepatic and renal function
- life expectancy > 3 months
- the patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- more than 1 cytotoxic chemotherapy regimen for metastatic disease
- prior therapy with mitoxantrone for prostate cancer
- history of prior treatment with agents directly inhibiting PDGF[R]
- radiotherapy = 21 days prior to first dose of IMC-3G3
- any investigational therapy within 30 days of randomization
- prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radio nucleotide therapy and has either ongoing evidence of bone marrow dysfunction or bone pain that is poorly controlled in the opinion of the investigator
- ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding, other serious uncontrolled medical disorders
- known or suspected brain or leptomeningeal metastases

Study & Design

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