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Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies

A Phase 1, Open-Label, Absolute Bioavailability Study of Vemurafenib in Patients With BRAF^V600 Mutation-Positive Malignancies

NCT02441465•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to characterize the pharmacokinetics (PK) of a single intravenous (IV) infusion of 14C-labeled vemurafenib administered shortly after an oral dose of vemurafenib and following multiple oral doses of vemurafenib twice daily (BID) at steady state as well as to estimate the absolute bioavailability of multiple oral doses of vemurafenib BID at steady state in participants with BRAF\^V600 mutation-positive malignancies. The study has two periods: Period A and Period B. During Period A, participants will receive vemurafenib BID orally from Day 1 to Day 20 and during Period B, participants will receive single IV infusion of 14C-labeled vemurafenib along with vemurafenib BID oral dose.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with either unresectable or metastatic melanoma positive for the BRAF\^V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, and for whom vemurafenib is an accepted standard of care or where there is no other generally accepted standard of care
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
•Life expectancy greater than or equal to (\>/=) 12 weeks
•Full recovery from the effects of any major surgery or significant traumatic injury within 14 days from the first dose of study drug
•Adequate hematologic and end organ function as defined by laboratory results obtained within 2 weeks prior to administration of study drug on Day 1
•Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use two effective methods of contraception during the study and at least 6 months after completion of the study drug
•Negative serum pregnancy test results within 7 days prior to Day 1 in women of childbearing potential
•Absence of any psychological, familial, or sociological condition, or geographical constraints that could potentially hamper compliance with the study protocol and follow-up schedule

Exclusion Criteria

•Prior anti-cancer therapy before the administration of study drug on Day 1
•Invasive malignancy other than BRAF mutant melanoma or other qualifying malignant tumor with BRAF\^V600 mutation within the past 5 years
•History of clinically significant cardiac or pulmonary dysfunction
•Active central nervous system lesions
•Current, severe, uncontrolled systemic disease
•Inability or unwillingness to swallow tablets
•History of malabsorption, stomach or intestinal surgery/resection, or other condition that would potentially alter absorption and/or excretion of orally administered drugs
•History of clinically significant liver disease
•Active autoimmune disease
•Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment
+9 more criteria

Locations (1)

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary

Key Dates

Start Date

August 13, 2015

Primary Completion Date

August 18, 2016

Completion Date

January 9, 2017

Last Updated

November 14, 2017

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma, Cancer

Interventions

Vemurafenib

DRUG

14C-Labeled Vemurafenib

DRUG