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Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT01907802•National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•PRE-REGISTRATION ELIGIBILITY CRITERIA
•Willing to provide tissue as required per protocol for central BRAF\^V600X mutation testing
•* NOTE: patients with prior BRAF\^600X testing that demonstrate a mutation at V600X will be allowed to enroll prior to central testing if the assay was performed at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory assay; this includes THxID, BRAF Detection Kit, Cobas 4800 BRAF600 mutation test and other CLIA-certified assays available at participating institutions
•Patients with unknown BRAF\^600X status: histologically confirmed melanoma, papillary thyroid, cholangiocarcinoma or testicular cancer that is metastatic or unresectable and for which the investigator feels a BRAF\^600X targeted agent is a reasonable treatment
•* NOTE: patient must be screened by central BRAF testing and must demonstrate a V600 mutation prior to start of study agent
•* Note: other tumor types without known BRAF\^600X mutations will not be eligible for central testing
•Ability to understand and willingness to sign written informed consent
•Life expectancy of \> 3 months
•REGISTRATION ELIGIBILITY CRITERIA
•Patients with known BRAF\^V600X mutation: patients must have BRAF\^V600X mutated, histologically confirmed cancer that is metastatic or unresectable and for which curative or standard therapies do not exist or are no longer effective
+33 more criteria

Exclusion Criteria

•Patients with active biliary obstruction; NOTE: patients for which a shunt has been in place for at least 10 days prior to the first dose of dabrafenib are allowed
•Reduced left ventricular ejection fraction (\< 50%) or other evidence of cardiac dysfunction as determined by the investigator
•Use of an investigational anti-cancer drug within 28 days preceding the first dose of dabrafenib
•Patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450 family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible
•* For patients on intermediate inducers or inhibitors, attempts should be made to switch to an alternative agent or delay enrollment until treatment course with concomitant agent completed; if not possible, patient may be enrolled if it is felt to be in the patients best interest as decided by the investigator
•* Weak inhibitors of CYP3A or CYP2C8 should be used with caution and attempts made to limit their use or find alternative agents, if possible
•Warfarin use is provisionally allowed
•Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) grade 2 or higher from previous anti-cancer therapy, except alopecia
•Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; Note: patients not on antiretroviral therapies are eligible for this study
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
+15 more criteria

Locations (18)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Key Dates

Start Date

August 23, 2013

Primary Completion Date

December 16, 2015

Completion Date

December 16, 2015

Last Updated

August 14, 2018

Enrollment

ACTUAL participants

Conditions

BRAF Gene MutationHepatic ComplicationRenal FailureSolid Neoplasm

Interventions

Dabrafenib

DRUG

Laboratory Biomarker Analysis

OTHER

Pharmacogenomic Study

OTHER

Pharmacological Study

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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