A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
Metastatic Melanoma
Interventions
DRUG

RAF265

A liquid nonaqueous oral formulation. Switched to a tablet formulations with was 60% bioavailable, relative to the liquid at 50mg dose. The liquid dose will be multiplied by a factor of 1.67 to achieve a comparable tablet dose. Tablets are available in 10mg and 50mg strengths.

Trial Locations (11)

8091

Novartis Investigative Site, Zurich

15232

University of Pittsburgh Cancer Institute Dept of Hillman Cancer Center, Pittsburgh

19104

University of Pennsylvania Health System Dept of Hospital of UnivofPenn, Philadelphia

21231

Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Medical Oncology, Baltimore

30912

Georgia Regents University Cancer Clinical Research Unit, Augusta

37232

Vanderbilt University Medical Center Dept. of Cancer Center, Nashville

80045

University of Colorado Univ.ofColoradoCancerCenter, Aurora

02114

Massachusetts General Hospital Dept of Cancer for Melanoma, Boston

02115

Dana Farber Cancer Institute DFCI, Boston

02215

Beth Israel Deaconess Medical Center Dept.ofBethIsraelDeaconess(3), Boston

77030-4009

University of Texas/MD Anderson Cancer Center Onc. Dept,, Houston

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY