NCT02323906

Safety and Efficacy Study of CC-122 Combined With Sorafenib for Primary Liver Cancer

A Phase 1b, Multi-Center, Open-Label, Dose Finding Study of CC-122 in Combination With Sorafenib in Subjects With Unresectable Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in combination with sorafenib for subjects with unresectable HCC who have received no prior systemic therapy for HCC. The dose escalation phase of the study will explore several dose levels of CC-122 in combination with sorafenib, followed by an expansion part of the study using the optimal combination dose regimen.

Detailed description

The primary objective of the study is to determine the safety and tolerability of CC-122 administered orally in combination with sorafenib, and to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D). The secondary objective of the study is to determine the preliminary efficacy of CC-122 in combination with sorafenib, based on response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	CC-122	Investigational new drug
DRUG	Sorafenib	Kinase inhibitor

Timeline

• Start date: 2015-01-16
• Primary completion: 2016-12-21
• Completion: 2016-12-21
• First posted: 2014-12-24
• Last updated: 2017-03-20

Locations

8 sites across 1 country: United States