Safety and Efficacy Study of CC-122 Combined With Sorafenib for Primary Liver Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02323906|
Recruitment Status : Terminated (Slow enrollment and business decision. No safety concerns were identified for the study drugs.)
First Posted : December 24, 2014
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: CC-122 Drug: Sorafenib||Phase 1|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b, Multi-Center, Open-Label, Dose Finding Study of CC-122 in Combination With Sorafenib in Subjects With Unresectable Hepatocellular Carcinoma|
|Actual Study Start Date :||January 16, 2015|
|Actual Primary Completion Date :||December 21, 2016|
|Actual Study Completion Date :||December 21, 2016|
Experimental: CC-122 + Fixed-dose Sorafenib
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.
Investigational new drug
Other Name: Nexavar
- Adverse Event [ Time Frame: Up to 3 years ]Number of Participants with Adverse Events
- Dose-Limiting Toxicity (DLT) [ Time Frame: 28 Days ]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).
- Overall Response Rate (ORR) [ Time Frame: Up to 4 years ]Percentage of subjects with complete response or partial response using Response Evaluation Criteria in Solid Tumor (RECIST 1.1).
- Disease control rate (DCR) [ Time Frame: Up to 4 years ]Percentage of subjects with complete response, partial response or stable disease using Response Evaluation Criteria in Solid Tumor (RECIST 1.1).
- Duration of response (DoR) [ Time Frame: Up to 4 years ]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.
- Progression-free survival [ Time Frame: Up to 4 years ]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.
- Overall survival [ Time Frame: Up to 4 years ]Number of participants who survive and the time from the first dose to death with any cause.
- Time to progression (TTP) [ Time Frame: Up to 4 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323906
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94115|
|United States, Florida|
|University of Florida College of Med|
|Gainesville, Florida, United States, 32610-0277|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-528|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, South Carolina|
|Greenville Hospital System|
|Greenville, South Carolina, United States, 29605|
|United States, Utah|
|University of Utah Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|Study Director:||Kristen Hege, MD||Celgene Corporation|