Spots Global Cancer Trial Database for A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma
Official Title: 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.
Study ID: NCT00304525
Conditions
Interventions
Study Description
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 II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec 2011.
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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Zürich, , Switzerland
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmeceuticals
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
