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Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors

NCT01713972 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-03-01

No results posted yet for this study

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

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Manisha Shah, MD · Ohio State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-19
Primary Completion
2016-07-30
Completion
2018-12-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01713972 on ClinicalTrials.gov