A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma
NCT ID: NCT00304525
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
104 participants
INTERVENTIONAL
2006-04-30
2013-11-30
Brief Summary
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Phase II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec 2011.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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RAF265 - Arm 1
Patients received 10mg RAF265 as a once weekly dose until progressive disease was confirmed.
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.
RAF265 - Arm 2
RAF265 is given as a single "PK run-in" dose, a single loading dose on day 1 of cycle 1, followed by once daily maintenance doses.
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.
RAF265 - Arm 3
Patients were treated with once weekly dosing of RAF265
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.
RAF265 - Arm 4
Patients with locally advanced or metastatic melanoma will utilize a dose close to or at the MTD/RPTD of the liquid formulation that was determined in Arm 2.
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.
RAF265 - Arm 5
RAF265 was administered as a continuous dose for 2 weeks followed by a dose holiday of 1 week.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. ECOG performance status of 0 or 1
4. No concurrent anticancer or investigational therapy for at least 4 weeks prior to enrollment
5. No major surgery for at least 4 weeks prior to enrollment
Exclusion Criteria
2. History of primary central nervous system tumor or brain metastases
3. History of melena, hematemesis, or hemoptysis within the last 3 months
4. Previous therapy with certain molecularly targeted agents
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmeceuticals
Locations
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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
Countries
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Related Links
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CRAF265A2101 Results at Novartis Clinical Trial Results Website
Other Identifiers
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2007-005367-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAF265A2101
Identifier Type: -
Identifier Source: org_study_id
NCT00324935
Identifier Type: -
Identifier Source: nct_alias