Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction

Part of paid clinical trials in Sacramento, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02070549
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Liver
  • Metastatic Malignant Solid Neoplasm
  • Unresectable Solid Neoplasm

Eligibility Criteria

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

Interventions

Study Details

This phase I trial studies the side effects and best dose of trametinib in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) with or without liver (hepatic) dysfunction. Trametinib may stop the growth of tumor cells by blocking proteins needed for cell growth. When these proteins are blocked, the growth of cancer cells may be stopped and the cancer cells will then die. Hepatic dysfunction is frequently found in patients with advanced cancer and usually prevents patients from receiving standard treatments or from participating in clinical trials. Patients may also need dose adjustments or absorb drugs differently. Trametinib may be a better treatment for patients with advanced cancers and hepatic dysfunction.

Key Dates

Start date
Mar 10, 2014
Status verified
Feb 2025
Primary completion
Dec 18, 2024
Completion
Dec 18, 2024

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trametinib)
    Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose of trametinib [ Time Frame: 28 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Moffitt Cancer CenterTampaFlorida33612-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Sacramento, CA

By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CAMoffitt Cancer Center· Tampa, FLUniversity of Chicago Comprehensive Cancer Center· Chicago, ILWayne State University/Karmanos Cancer Institute· Detroit, MIWashington University School of Medicine· St Louis, MORutgers Cancer Institute of New Jersey· New Brunswick, NJ

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