Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Capmatinib
INC280 · 7 trials · 6 indications
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Overall response rate is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), as per RECIST 1.1 (Overall Response (OR) = CR + PR). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
midazolam and caffeine pharmacokinetic parameters
midazolam and caffeine pharmacokinetic parameter
midazolam and caffeine pharmacokinetic parameter
midazolam and caffeine pharmacokinetic parameter
midazolam and caffeine pharmacokinetic parameter
midazolam and caffeine pharmacokinetic parameter
midazolam and caffeine pharmacokinetic parameter
midazolam and caffeine pharmacokinetic parameter
digoxin and rosuvastatin pharmacokinetics parameters
digoxin and rosuvastatin pharmacokinetics parameters
digoxin and rosuvastatin pharmacokinetics parameters
digoxin and rosuvastatin pharmacokinetics parameters
digoxin and rosuvastatin pharmacokinetics parameters
digoxin and rosuvastatin pharmacokinetics parameters
digoxin and rosuvastatin pharmacokinetics parameters
digoxin and rosuvastatin pharmacokinetics parameters
INC280 pharmacokinetic parameters
INC280 pharmacokinetic parameters
INC280 pharmacokinetic parameters
INC280 pharmacokinetic parameters
INC280 pharmacokinetic parameters
INC280 pharmacokinetic parameters
INC280 pharmacokinetic parameters
Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.
| Arm | Type | Description |
|---|---|---|
| INC280 100 mg Cap QD Phase Ib | EXPERIMENTAL | cap=capsule; QD=once daily |
| INC280 200 mg Cap QD Phase Ib | EXPERIMENTAL | cap=capsule; QD=once daily |
| INC280 400 mg Cap QD Phase Ib | EXPERIMENTAL | cap=capsule; QD=once daily |
| INC280 800 mg Cap QD Phase Ib | EXPERIMENTAL | cap=capsule; QD=once daily |
| INC280 200 mg Cap BID Phase Ib | EXPERIMENTAL | cap=capsule; BID=twice daily |
| INC280 400 mg Cap BID Phase Ib | EXPERIMENTAL | cap=capsule; BID=twice daily |
| INC280 600 mg Cap BID Phase Ib | EXPERIMENTAL | cap=capsule; BID=twice daily |
| INC280 200 mg Tab BID Phase Ib | EXPERIMENTAL | tab=tablet; BID=twice daily |
| INC280 400 mg Tab BID Phase Ib | EXPERIMENTAL | tab=tablet; BID=twice daily |
| INC280 400 mg Cap BID Phase II | EXPERIMENTAL | cap=capsule; BID=twice daily |
| INC280 400 mg Tab BID Phase II | EXPERIMENTAL | tab=tablet; BID=twice daily |
| INC280 | EXPERIMENTAL | - |
| Normal hepatic function | EXPERIMENTAL | Subjects with normal hepatic function |
| Mild hepatic impairment | EXPERIMENTAL | Subjects with mild hepatic impairment |
| Moderate hepatic impairment | EXPERIMENTAL | Subjects with moderate hepatic impairment |
| Severe hepatic impairment | EXPERIMENTAL | Subjects with severe hepatic impairment |
| Name | Type | Description |
|---|---|---|
| INC280 | DRUG | During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose. |
| Gefitinib | DRUG | Gefitinib 250 mg taken once daily |
| Midazolam | DRUG | - |
| Caffeine | DRUG | - |
| digoxin | DRUG | - |
| rosuvastatin | DRUG | - |
Inclusion Criteria: * Documented EGFR mutation * Documented c-MET dysregulation * Prior clinical benefit on EGFR inhibitors and then subsequent progression -≥ 18 year old * Life expectancy of ≥ 3 months * ECOG performance status ≤ 2 Exclusion Criteria: * Unable to swallow tables once or twice ...
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Capmatinib is an investigational small molecule being studied for the treatment of non-small cell lung cancer, solid tumors, advanced solid tumors that are cMET-dependent, and hepatic impairment. It is also being evaluated in patients with cMET dysregulation advanced solid tumors. The drug is in Phase 2 clinical development.
Capmatinib is a kinase inhibitor, belonging to the -tinib class of drugs. It targets the cMET pathway, as indicated by its use in cMET-dependent and cMET dysregulation advanced solid tumors. The drug is designed to inhibit this specific kinase to potentially treat certain cancers.
Capmatinib is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
Capmatinib is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is studying the drug in patients with advanced solid tumors that are cMET-dependent.
Capmatinib has been studied in several clinical trials. NCT02414139 is a completed Phase 2 study in non-small cell lung cancer. NCT02474537 is a completed Phase 1 study in hepatic impairment. NCT03040973 is an active Phase 2 trial in cMET-dependent advanced solid tumors. NCT03647488 is a completed Phase 2 study in non-small cell lung cancer.
Yes, Capmatinib is also known as INC280. Clinical trials have used both names to refer to the same drug. For example, the study NCT02414139 is titled 'Study of Oral cMET Inhibitor INC280' and investigates the drug Capmatinib in patients with non-small cell lung cancer.