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Study was cancelled by Sponsor.
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This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib.
Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding.
Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).
Study was cancelled by Sponsor prior to enrollment of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INC280 plus best supportive care | Experimental | Approximately 46 patients will be treated with INC280 600 mg twice a day plus best supportive care. |
|
| Placebo plus best supportive care | Placebo Comparator | Approximately 23 patients will be treated with matching placebo twice a day plus best supportive care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INC280 | Drug | INC280 will be administered orally and continuously on a twice a day dosing schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 | Time to progression is the time from the date of baseline evaluation to the date of the first documented radiological confirmation of disease progression. | baseline, 6 weeks up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Best overall response is defined as the best response recorded from the date of randomization until the date of last tumor assessment per RECIST version 1.1. | date of treatment, every 6 weeks up to 6 months |
| Overall Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Mass General Hospital | Boston | Massachusetts | 02115 | United States | ||
| Research Medical Center Onc Dept |
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| Placebo | Drug | Placebo will be administered orally and continuously on a twice a day dosing schedule. |
|
Overall Response Rate is defined as the proportion of patients with a best overall response of complete response or partial response at any time on study per RECIST version 1.1. |
| baseline, every 6 weeks up to 6 months |
| Disease Control Rate | Disease control rate is defined as the proportion of patients with a best overall response of complete response, partial response or stable disease at any time on study per RECIST version 1.1. | baseline, every 6 weeks up to 6 months |
| Progression Free Survival | Progression free survival is defined as the time from date of randomization to the date of the first radiologically documented progression or death due to any cause. If a patient has not experienced radiologically documented progression or death, progression free survival is censored at the date of last adequate tumor assessment. | randomization, every 6 weeks up to 6 months |
| Overall Survival | Overall survival is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact. | randomization until death, average 10 months |
| Safety: adverse events, serious adverse events | Frequency, duration and severity of adverse events. | From baseline until 30 days post study treatment |
| Safety: hematology and chemistry values, vital signs, electrocardiograms | Change from baseline values. | From baseline until end of treatment, average 6 months from baseline |
| Tolerability of study drug | Tolerability will be assessed by summarizing the number of dose interruptions, dose reductions and dose intensity. | From date of randomization until end of treatment, average 6 months from baseline |
| Kansas City |
| Missouri |
| 64132 |
| United States |
| Novartis Investigative Site | Kogarah | New South Wales | 2217 | Australia |
| Novartis Investigative Site | Heidelberg | Victoria | 3084 | Australia |
| Novartis Investigative Site | Clichy | 92110 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Montpellier | 34298 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Hong Kong SAR | Hong Kong |
| Novartis Investigative Site | Córdoba | Andalusia | 14004 | Spain |
| Novartis Investigative Site | Bern | 3010 | Switzerland |
| Novartis Investigative Site | Geneva | 1211 | Switzerland |
| ID | Term |
|---|---|
| C000613976 | capmatinib |
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