NCT02292173

Trametinib in Combination With Sorafenib in Patients With Advanced Hepatocellular Cancer

A Phase 1a/1b Trial of Trametinib in Combination With Sorafenib in Patients With Advanced Hepatocellular Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Each cycle will last for 4 weeks. Sorafenib and trametinib will be administered orally on continuous basis. During the first cycle sorafenib will be started on day 1 and trametinib on day 8 to improve tolerance. Participants will get restaging scans every 2 cycles. Participants will continue to receive treatment if they have a stable disease or a better response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.

Conditions

• Hepatocellular Cancer
• Liver Cancer

Interventions

Type	Name	Description
DRUG	Trametinib	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)
DRUG	Sorafenib	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)

Timeline

• Start date: 2015-02-18
• Primary completion: 2018-12-18
• Completion: 2021-01-01
• First posted: 2014-11-17
• Last updated: 2021-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study