Metastatic Castration-Refractory Prostate Cancer MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: IMC-3G3
Product Code: IMC-3G3
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IMC-3G3
CAS Number: Not assigned
Current Sponsor code: IMC-3G3
Other descriptive name: recom
Sponsors
ImClone LLC
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare treatment Arm A (IMC-3G3 plus mitoxantrone plus prednisone) and Arm B (mitoxantrone plus prednisone) in terms of progression-free survival (PFS).;Secondary Objective: The secondary objectives of this study are to: - Compare the overall survival (OS) of both arms - Compare the objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) of both arms - Evaluate the prostate-specific antigen (PSA) doubling time in both arms and evaluate the PSA response rate according to two definitions: 1) response manifested by a 50% decline in pretreatment PSA and 2) response defined by a 30% decline in pretreatment PSA at 12 weeks - Assess the safety and tolerability of IMC-3G3 (with prednisone) with and without mitoxantrone - Explore circulating tumor cells (CTC) in whole blood and PDGFRa expression, and their associations with efficacy endpoints - Examine the pharmacokinetics (PK) of IMC-3G3 in combination with mitoxantrone and prednisone and immunogenicity of IMC-3G3.;Primary end point(s): Progression-Free Survival (see section 12.5 for details). ;Timepoint(s) of evaluation of this end point: 21 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): include OS/ORR/PSA/PGDFR-alpha/cmax/antibody assessment ;Timepoint(s) of evaluation of this end point: 21 months | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Italy, Spain
Contacts
Public ContactClinical Trials Info
Eli Lilly and Company
Outcome results
None listed