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

Completed · Phase 1/Phase 2

Conditions studied: Metastatic Melanoma

In brief

The purpose of this study is to determine the safety profile, pharmacokinetics, pharmacodynamics and maximum tolerated dose of RAF265 in patients with locally advanced and metastatic melanoma. Phase II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec 2011.

Key facts

Study ID

NCT00304525

Run by

Novartis Pharmaceuticals

People needed

104

Starts

2006-04-01

Expected to finish

2013-11-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of melanoma, locally advanced AJCC Stage IIIB to metastatic Stage IV
• Measurable disease - at least one lesion measured in at least one dimension as ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan
• ECOG performance status of 0 or 1
• No concurrent anticancer or investigational therapy for at least 4 weeks prior to enrollment
• No major surgery for at least 4 weeks prior to enrollment

You may not qualify if…

• Significant cardiac disease or other significant medical/psychiatric disease
• History of primary central nervous system tumor or brain metastases
• History of melena, hematemesis, or hemoptysis within the last 3 months
• Previous therapy with certain molecularly targeted agents

Where it is running

• University of Colorado Univ.ofColoradoCancerCenter — Aurora, Colorado, United States
• Georgia Regents University Cancer Clinical Research Unit — Augusta, Georgia, United States
• Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Medical Oncology — Baltimore, Maryland, United States
• Massachusetts General Hospital Dept of Cancer for Melanoma — Boston, Massachusetts, United States
• Dana Farber Cancer Institute DFCI — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center Dept.ofBethIsraelDeaconess(3) — Boston, Massachusetts, United States
• University of Pennsylvania Health System Dept of Hospital of UnivofPenn — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Cancer Institute Dept of Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center Dept. of Cancer Center — Nashville, Tennessee, United States
• University of Texas/MD Anderson Cancer Center Onc. Dept, — Houston, Texas, United States
• Novartis Investigative Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

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