Spots Global Cancer Trial Database for A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
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Trial Identification
Brief Title: A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Official Title: A Phase I, Open-Label, Multicenter, Three-Period, One-Sequence Study To Investigate The Effect Of Ketoconazole On The Pharmacokinetics Of A Single Oral Dose Of 960 Mg Of Vemurafenib
Study ID: NCT01765556
Conditions
Study Description
Brief Summary: This open-label, multi-center, three-period, one sequence study will investigate the effect of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in Periods B and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 19 days.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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