Status:
COMPLETED
A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
The Ras/Raf/MEK/ERK pathway plays a prominent role in controlling several key cellular functions including growth, proliferation and survival. B-Raf is a member of the Ras/Raf/MEK/ERK pathway and is f...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00304525
Start Date
April 1 2006
End Date
November 1 2013
Last Update
December 19 2020
Active Locations (11)
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1
University of Colorado Univ.ofColoradoCancerCenter
Aurora, Colorado, United States, 80045
2
Georgia Regents University Cancer Clinical Research Unit
Augusta, Georgia, United States, 30912
3
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Medical Oncology
Baltimore, Maryland, United States, 21231
4
Massachusetts General Hospital Dept of Cancer for Melanoma
Boston, Massachusetts, United States, 02114