Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Manisha Shah
Study ID
NCT01713972
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dabrafenib — DRUG
    Given PO
  • pazopanib hydrochloride — DRUG
    Given PO
  • Correlative studies — OTHER
    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

Study Details

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

Key Dates

Start date
Nov 19, 2012
Status verified
Feb 2019
Primary completion
Jul 30, 2016
Completion
Dec 26, 2018

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (dabrafenib, pazopanib hydrochloride)
    Patients receive dabrafenib PO BID on days 1-28 (once daily on day 1 and BID on days 3-28 of course 1), and pazopanib hydrochloride PO 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.
  • 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

Primary Outcome Measure

Incidence of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4 [ Time Frame: 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Ohio State University Medical CenterColumbusOhio43210-
University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Columbus, OH

By research site
Ohio State University Medical Center· Columbus, OHUniversity of Texas M.D. Anderson Cancer Center· Houston, TX

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