A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Melanoma
Intervention: BMS-734016 (MDX-010) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bristol-Myers Squibb
Summary
The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010
(BMS-734016) administered with or without Prophylactic Oral Budesonide.
Clinical Details
Official title: Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety Study
Primary outcome: Rate of Grade 2,3,4 Diarrhea - patients on study drug.
Secondary outcome: Safety monitored w/follow-up period. Assess Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma
(excluding ocular melanoma)
- Flexible Sigmoidoscopy and colonic biopsy required
Exclusion Criteria:
- Patients with active, untreated central nervous system metastasis. Patients with
autoimmune disease.
Locations and Contacts
Local Institution, Tel Aviv IL-64239, Israel
Local Institution, Forli' 47100, Italy
Local Institution, Lima 43, Peru
San Francisco Oncology Associates, San Francisco, California 94115, United States
Usc Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States
The Angeles Clinic And Research Institution, Santa Monica, California 90404, United States
Local Institution, Moncton, New Brunswick E1C 6Z8, Canada
Carolinas Medical Center, Charlotte, North Carolina 28203, United States
Local Institution, Kitchener, Ontario N2G 1G3, Canada
University Of Washington Medical Center, Seattle, Washington 98109, United States
Local Institution, Hull, Yorkshire HU8 9HE, United Kingdom
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: November 2005
Ending date: July 2007
Last updated: November 1, 2007
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