Clinical trial · Interventional
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
NCT01737827CI-TRIAL-00080998terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study recruitment was ended due to difficulties in identifying subjects who meet the eligibility criteria and therefore the study never reached its planned sample size per protocol. The study termination was not due to any safety concerns.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma With c-MET Dysregulation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INC280 | Drug | Capmatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INC280
- description
- The protocol consisted of two independent parts (Dose-Determining Part and Dose Expansion Part). Patients were treated with INC280 300 mg twice a day in the Dose-Determining Part. The dose for the Expansion Part could be lower, equal or higher than in the Dose-Determining Part and was determined after the Dose Determining Part at the dose decision analysis.
- interventionNames
- Drug: INC280
Primary outcomes (1)
- measure
- Time to Progression (TTP) by Investigator Assessment Per RECIST v1.1
- timeFrame
- Up to approximately 8 years and 2 months
- description
- TTP is defined as the time from the date of treatment start to the date of the first documented radiological confirmation of disease progression or death due to underlying cancer. Tumor response was based on investigator assessment per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. For RECIST v1.1, Progressive disease (PD) = At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. If a patient had not had the event at the date of analysis cut-off or when he/she received any further anti-neoplastic therapy, TTP was censored at the time of the last adequate assessment. TTP was estimated using the Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. 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.
References
Publications (1)
- DERIVEDQin S, Chan SL, Sukeepaisarnjaroen W, Han G, Choo SP, Sriuranpong V, Pan H, Yau T, Guo Y, Chen M, Ren Z, Xu J, Yen CJ, Lin ZZ, Manenti L, Gu Y, Sun Y, Tiedt R, Hao L, Song W, Tanwandee T. A phase II study of the efficacy and safety of the MET inhibitor capmatinib (INC280) in patients with advanced hepatocellular carcinoma. Ther Adv Med Oncol. 2019 Dec 11;11:1758835919889001. doi: 10.1177/1758835919889001. eCollection 2019. PMID 31853265