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



Status:Archived
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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A Phase I/II, Open-label, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RAF265 (CHIR-265)Administered Orally to Patients With Locally Advanced or Metastatic Melanoma.


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.


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 frequently mutated in melanoma resulting in activation of the
MAPK pathway. RAF265 is a novel, orally active, small molecule with potent inhibitory
activity against B-Raf kinase and additional antiangiogenic activity through inhibition of
vascular endothelial growth factor receptor type 2 (VEGFR-2) in non-clinical studies.

The primary objectives of this study are to determine the maximum tolerated dose (MTD), dose
limiting toxicities (DLTs), and the safety profile of RAF265 when administered orally to
subjects with locally advanced or metastatic melanoma; to determine the plasma
pharmacokinetics (PKs) of orally administered RAF265; and to evaluate potential
pharmacodynamic effects of RAF265 using tumor biopsies, peripheral blood samples, and tumor
imaging.


We found this trial at
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sites
1400 South Orange Avenue
Orlando, Florida 32806
407-648-3800
M. D. Anderson Cancer Center Welcome to UF Health Cancer Center at Orlando Health. For...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Med College of Georgia Georgia Regents University, home of the Medical College of Georgia, is...
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Augusta, GA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Franklin, TN
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Lutherville, Maryland 21218
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Lutherville, MD
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Pittsburgh, Pennsylvania 15260
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Pittsburgh, PA
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