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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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13 May 2013 |
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Main ID: |
NCT01001299 |
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Date of registration:
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21/10/2009 |
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Primary sponsor: |
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Public title:
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A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma
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Scientific title:
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A Multi-center, Open-label, Study to Investigate the Pharmacokinetic Interaction of RO5185426 With a "Cocktail" of Five Probe Drugs for CYP450 Dependent Metabolism in Patients With Previously Treated and Untreated Metastatic Melanoma |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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22 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01001299 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patient >/= 18 years of age
- Malignant melanoma (Stage IV, AJCC)
- Patients who are treatment-naive or have received prior systemic treatments for
metastatic melanoma. Time elapsed between previous treatment for metastatic disease
and first administration of study drug must be at least 28 days
- Positive tested for BRAF mutation
- Patients must not be poor metabolizers of CYP450 enzymes 2C9, 2C19, or 2D6 as
determined by genotyping
- Measurable disease by RECIST criteria
- Negative pregnancy test; for fertile men and women, effective contraception during
treatment and for 6 months after completion
Exclusion Criteria:
- Active CNS lesions on CT/MRI within 28 days prior to enrollment
- History of known spinal cord compression, or carcinomatous meningitis
- Severe cardiovascular disease within 6 months prior to study
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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Malignant Melanoma
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Intervention(s)
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Drug: Drug cocktail
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Drug: RO5185426
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Primary Outcome(s)
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Pharmacokinetics: blood concentration levels of RO5185426 and of the 5 drugs of the drug cocktail and their metabolites
[Time Frame: Multiple sampling, days 1-25]
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Secondary Outcome(s)
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Efficacy: best overall response rate, duration of response, time to response, progression-free survival, overall survival
[Time Frame: Tumour assessment on day 28 and every 8 weeks thereafter]
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Safety and tolerability: AEs, laboratory parameters
[Time Frame: Throughout study, laboratory assessments on days 1, 2, 5, 18, 20, 22 and every 1-2 cycles thereafter]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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