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Sorafenib

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A dose escalation and expansion clinical study of CC-122 in combination with sorafenib in subjects with unresectable HCC who have received no prior systemic therapy for HCC.

The dose escalation part of the study will explore several dose levels of CC-122 in combination with sorafenib, followed by an expansion part.

CC-122

Kristen Hege, MD

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.

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)

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

Number of Participants with Adverse Events

Number of participants with a DLT. A DLT is defined as a treatment-related AE(s) occurring in Cycle 1 (including predose assessments on Cycle 2 Day 1).

Percentage of subjects with complete response or partial response using Response Evaluation Criteria in Solid Tumor (RECIST 1.1).

Percentage of subjects with complete response, partial response or stable disease using Response Evaluation Criteria in Solid Tumor (RECIST 1.1).

Duration from the time of measurement criteria are first met for complete response or partial response until tumor progression using RECIST 1.1 or death.

Number of participants who survive without tumor progression using RECIST 1.1and time from the first dose date until objective tumor progression or death, whichever occurs first.

Number of participants who survive and the time from the first dose to death with any cause.

Number of participants who do not have tumor progression using RECIST 1.1 and the time from the first dose date until objective tumor progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy Study of CC-122 Combined With Sorafenib for Primary Liver Cancer	NCT02323906	Carcinoma, Hepa...	CC-122 Sorafenib	18 Years -	Celgene
Safety and Efficacy Study of CC-122 Combined With Sorafenib for Primary Liver Cancer	NCT02323906	Carcinoma, Hepa...	CC-122 Sorafenib	18 Years -	Celgene

Spots Global Cancer Trial Database for unresectable hccadvanced,