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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Authority:

United States: Food and Drug Administration

Study ID:

CA184-007

NCT ID:

NCT00135408

Start Date:

November 2005

Completion Date:

July 2007

Related Keywords:

  • Malignant Melanoma
  • Unresectable Stage III or IV Malignant Melanoma
  • Melanoma

Name

Location
University of Washington Medical Center Seattle, Washington  98195-6043
Carolinas Medical Center Charlotte, North Carolina  28232-2861
USC Norris Comprehensive Cancer Center Los Angeles, California  90089
San Francisco Oncology Associates San Francisco, California  94115
The Angeles Clinic And Research Institution Santa Monica, California  90404