Trametinib in Combination With Sorafenib in Patients With Advanced Hepatocellular Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02292173
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Trametinib — DRUG
    Dose Escalation: Level 1: 1 mg daily. Level 2: 1.5 mg daily. Level 3: 1.5 mg daily. Level 4: 2 mg daily. Dose Expansion: Maximum Tolerated Dose (MTD)
  • Sorafenib — DRUG
    Dose Escalation: Level 1: 200 mg twice daily. Level 2: 200 mg twice daily. Level 3: 400 mg twice daily. Level 4: 400 mg twice daily. Dose Expansion: Maximum Tolerated Dose (MTD)

Study Details

The main purpose of this study is to see whether the combination of trametinib and sorafenib can help people with hepatocellular cancer. Researchers also want to find out if the combination of trametinib and sorafenib is safe and tolerable.

Key Dates

Start date
Feb 18, 2015
Status verified
Jan 2021
Primary completion
Dec 18, 2018
Completion
Jan 31, 2021

Study Design

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

Arms

  • Experimental: Trametinib plus Sorafenib
    Dose Escalation Followed by Dose Expansion. Trametinib: Daily (To start on day 8 during cycle 1 and on day 1 from cycle 2 onwards), according to dose level upon entry. Sorafenib: Twice daily, according to dose level upon entry. Each cycle is repeated every 28 days.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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