NCT01713972

Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors

A Phase I Trial of Dabrafenib (BRAFi) and Pazopanib in Patients With BRAF-mutated Advanced Malignant Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Manisha Shah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of dabrafenib and pazopanib hydrochloride when given together in treating patients with advanced malignant tumors. Dabrafenib and pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of GSK2118436 (dabrafenib) given with pazopanib (pazopanib hydrochloride) as well as determining the maximum tolerated dosing regimen in patients with BRAF mutated advanced malignant tumors. SECONDARY OBJECTIVES: I. Evaluate pharmacokinetics of the two study drugs and identify potential drug-drug interactions. II. Determine pharmacogenomics with microarray testing. III. Perform genotyping of tumors and if objective tumor response rates are identified. IV. Assess objective tumor response rates. OUTLINE: This is a dose-escalation study. Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28 (once daily on day 1 and BID on days 3-28 of course 1), and pazopanib hydrochloride PO once daily (QD) on days 1-28 (days 2-28 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 for 4 weeks.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	dabrafenib	Given PO
DRUG	pazopanib hydrochloride	Given PO
OTHER	Correlative studies	Pharmacokinetic studies: Blood draw for various time points: Cycle 1 Days 1, 2, 3, 4 and 15; Cycle 2 Days 1, 2; and day 1 of Cycles 4, 6 and 12 * Pharmacogenomic studies: Blood draw on Cycle 1 Day 1 * Tumor genotyping: Archival tumor blocks or unstained slides * BRAF mutation quantification in circulating plasma DNA: Blood draw on Cycles 1-7 Day 1 and every other cycle thereafter; and at time of progression

Timeline

• Start date: 2012-11-19
• Primary completion: 2016-07-30
• Completion: 2018-12-26
• First posted: 2012-10-25
• Last updated: 2019-03-01

Locations

2 sites across 1 country: United States