A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Medarex
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00135408

Purpose

The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.

Condition	Intervention	Phase
Malignant Melanoma	Drug: Ipilimumab+ Placebo Drug: Ipilimumab+ Budesonide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Budesonide Ipilimumab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Rate of Grade 2,3,4 Diarrhea - patients on study drug.

Secondary Outcome Measures:

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 [ Time Frame: at Week 24 ]

Estimated Enrollment:	110
Study Start Date:	November 2005
Study Completion Date:	July 2007

Arms	Assigned Interventions
A1: Active Comparator	Drug: Ipilimumab+ Placebo Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
A2: Active Comparator	Drug: Ipilimumab+ Budesonide Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135408

Locations

United States, California
San Francisco Oncology Associates
San Francisco, California, United States, 94115
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
The Angeles Clinic And Research Institution
Santa Monica, California, United States, 90404
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Washington
University Of Washington Medical Center
Seattle, Washington, United States, 98109
Canada, New Brunswick
Local Institution
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Local Institution
Kitchener, Ontario, Canada, N2G 1G3
Israel
Local Institution
Tel Aviv, Israel, IL-64239
Italy
Local Institution
Forli', Italy, 47100
Peru
Local Institution
Lima, Peru, 43
United Kingdom, Yorkshire
Local Institution
Hull, Yorkshire, United Kingdom, HU8 9HE

Sponsors and Collaborators

Bristol-Myers Squibb

Medarex

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CA184-007
Study First Received:	August 25, 2005
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00135408 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Unresectable Stage III or IV Malignant Melanoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Autonomic Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 30, 2009