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Spots Global Cancer Trial Database for Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors

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Trial Identification

Brief Title: Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors

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

Study ID: NCT01713972

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ohio State University Medical Center, Columbus, Ohio, United States

University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

Contact Details

Name: Manisha Shah, MD

Affiliation: Ohio State University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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