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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00304525 |
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Date of registration:
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17/03/2006 |
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Primary sponsor: |
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Public title:
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A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma
CHIR-265-MEL01 |
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Scientific title:
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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. |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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170 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00304525 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Switzerland
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmeceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Confirmed diagnosis of melanoma, locally advanced AJCC Stage IIIB to metastatic Stage
IV
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:
1. Significant cardiac disease or other significant medical/psychiatric disease
2. History of primary central nervous system tumor or brain metastases onths
3. History of melena, hematemesis, or hemoptysis within the last 3 months
4. Previous therapy with certain molecularly targeted agents
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Melanoma
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Intervention(s)
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Drug: RAF265
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Primary Outcome(s)
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Dose limiting toxicities
[Time Frame: during the PK run-in phase and first cycle (28 day cycle)]
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Evaluate potential pharmacodynamic effects
[Time Frame: throughout the study]
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Maximum tolerated dose
[Time Frame: at the end of dose escalation]
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Pharmacokinetic profile
[Time Frame: throughout the study]
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Safety profile
[Time Frame: throughout the study]
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Secondary Outcome(s)
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Determine the recommended phase two dose
[Time Frame: at the end of dose escalation]
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Determine the response rate for BRAF mutant patients
[Time Frame: Every 2 months]
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Evaluate whether somatic mutations in BRAF and N-RAS genes are associated with modulation of pharmacodynamic markers and clinical response
[Time Frame: throughout the study]
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Secondary ID(s)
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2007-005367-10
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CRAF265A2101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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