NCT01907802

Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction

A Phase 1 and Pharmacokinetic Study of Dabrafenib (GSK2118436B) in Patients With BRAFV600X Mutations and Renal or Hepatic Dysfunction

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of dabrafenib in treating patients with solid tumors and kidney or liver dysfunction. Dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the toxicity profile and the maximum tolerated doses (MTDs) of dabrafenib in patients with v-raf murine sarcoma viral oncogene homolog B1 (BRAF)\^V600X mutations and renal or hepatic dysfunction. SECONDARY OBJECTIVES: I. To assess for tumor response and various times to clinical event. II. To provide dosing recommendations for dabrafenib in patients with varying degrees of hepatic and renal dysfunction for possible inclusion in the label. TERTIARY OBJECTIVES: I. To assess the pharmacokinetic and pharmacogenetic profile of dabrafenib and active metabolites. OUTLINE: This is a dose-escalation study. Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily \[QD\] on day 1 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

• BRAF Gene Mutation
• Hepatic Complication
• Renal Failure
• Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Dabrafenib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacogenomic Study	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2013-08-23
• Primary completion: 2015-12-16
• Completion: 2015-12-16
• First posted: 2013-07-25
• Last updated: 2018-08-14

Locations

18 sites across 2 countries: United States, Canada