GUMDROP : Trial to Compare the Efficacy of Ipilimumab in Asymptomatic or Minimally Symptomatic Patients with Metastatic Chemotherapy-Naive Castration Resistant Prostate Cancer

Created by Hiwot Guebre-Xabiher, last modified by Channing Paller on Apr 13, 2012

Description:

This is a double-blind, 2-arm, multi-center, Phase 3 study in subjects with asymptomatic or minimally symptomatic, chemotherapy-naive, castration resistant prostate cancer (CRPC) who have progressed despite receiving hormal therapies, and who have no know visceral metastates. The study will randomize approximately 600 eligible CRPC subjects at a 2:1 ratio stratified by the following factors:
• Eastern Cooperative oncology Group (ECOG) Performance Status (o vs 1)
• lactase dehydrogenase (LDH) (<200 vs = 200 IU/L)
• Pain (none vs minimal) and
• Region (US/Canada vs non-US/Canada)

Link:

Immunotherapy for prostate cancer

Site:

George Washington University-Medical Facutly Associates and Johns Hopkins Hospital

Principal Investigator:

Jeanny Aragon-Ching, M.D. and Charles Drake, M.D.