Study Efficacy and Safety of INC280 in Patients With Advanced Hepatocellular Carcinoma.

A Phase II, Open Label, Single Arm, Multicenter Study of INC280 Administered Orally in Adults With Advanced Hepatocellular Carcinoma

ClinicalTrials.gov Identifier: NCT01737827

Novartis Reference Number: CINC280X2201

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This study is to find out if INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway.

Condition 
Advanced Hepatocellular Carcinoma With c-MET Dysregulation
Phase 
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
38 participants
Start date 
Mar 25, 2013
Completion date 
Sep 27, 2020
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
INC280
INC280 will be administered orally and continuously on a twice a day dosing schedule.

Eligibility Criteria

Inclusion Criteria:

Confirmed c-MET pathway dysregulation.
Advanced hepatocellular carcinoma which could not be suitable for treatment with locoregional therapies or has progressed following locoregional therapy.
Measurable disease as determined by RECIST version 1.1.
Current cirrhotic status of Child-Pugh class A with no encephalopathy.
Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Received any prior systemic chemotherapy or molecular-targeted therapy for hepatocellular carcinoma such as sorafenib.
Previous treatment with c-MET inhibitor or hepatocyte growth factor targeting therapy.
Previous local therapy completed less than 4 weeks prior to dosing and, if present, any acute toxicity > grade 1.
Known active bleeding (e.g. bleeding from gastro-intestinal ulcers or esophageal varices) within 2 months prior to screening or with history or evidence of inherited bleeding diathesis or coagulopathy.
Clinically significant venous or arterial thrombotic disease within past 6 months.
History of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase risk of pancreatitis.
Other protocol-defined exclusion criteria may apply.

Study Locations

China
Novartis Investigative Site
-
Guangzhou, 510515
Guangdong
China
Novartis Investigative Site
-
Nanjing, 210002
Jiangsu
China
Novartis Investigative Site
-
Shanghai, 200032
Shanghai
China
Novartis Investigative Site
-
Xi'an, 710032
Shanxi
China
Novartis Investigative Site
-
Hangzhou, 310016
Zhejiang
China
Novartis Investigative Site
-
Beijing, 100039
-
China
Novartis Investigative Site
-
Guangzhou, 510060
-
China
Hong Kong
Novartis Investigative Site
-
Hong Kong,
-
Hong Kong
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore
Taiwan
Novartis Investigative Site
-
Tainan, 70403
Taiwan ROC
Taiwan
Novartis Investigative Site
-
Taipei, 10002
-
Taiwan
Thailand
Novartis Investigative Site
-
Khon Kaen, 40002
THA
Thailand
Novartis Investigative Site
-
Bangkok, 10330
-
Thailand
Novartis Investigative Site
-
Bangkok, 10700
-
Thailand

Have a question?

Call 1-999-669-6682 or email [email protected]