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INC280

Phase 2

Non-small Cell Lung Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Apr 8, 2021

Target and mechanism

Molecular targetMET
Target classInhibitor
ModalitySmall molecule

Also known as Capmatinib

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment161

FDA Designations

No designations recorded

Clinical trial landscape

INC280 · 7 trials · 6 indications

Phase 2 1Phase 1 6
NCT01610336A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi TreatmentNon-small Cell Lung Cancer
COMPLETED161 Analytics
PHASE2COMPLETED
A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase Ib: Frequency of Dose Limiting Toxicities (DLTs)
Up to 215 weeks

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.

Phase II : Overall Response Rate (ORR)
Until disease progression, up to 60.8 weeks

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.

Incidence of Dose limiting toxiticites (DLTs)
During the first 28 days on INC280 treatment; cycle = 21 days
Frequency of DLTs
During the first 28 days on INC280 treatment
Category of DLTs
During the first 28 days on INC280 treatment
AUClast for INC280
Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1
AUCtau for INC280
C1D1, C1D7, C1D15, C2D1, C3D1
Cmax for INC280
C1D1, C1D7, C1D15, C2D1, C3D1
Tmax
C1D1, C1D7, C1D15, C2D1, C3D1
AUClast of midazolam and caffeine
Up to 72 hours post midazolam and caffeine dose

midazolam and caffeine pharmacokinetic parameters

AUCinf of midazolam and caffeine
Up to 72 hours post midazolam and caffeine dose

midazolam and caffeine pharmacokinetic parameter

Lambda_z of midazolam and caffeine
Up to 72 hours post midazolam and caffeine dose

midazolam and caffeine pharmacokinetic parameter

Cmax of midazolam and caffeine
Up to 72 hours post midazolam and caffeine dose

midazolam and caffeine pharmacokinetic parameter

Tmax of midazolam and caffeine
Up to 72 hours post midazolam and caffeine dose

midazolam and caffeine pharmacokinetic parameter

T1/2 of midazolam and caffeine
Up to 72 hours post midazolam and caffeine dose

midazolam and caffeine pharmacokinetic parameter

CL/F of midazolam and caffeine
Up to 72 hours post midazolam and caffeine dose

midazolam and caffeine pharmacokinetic parameter

Vz/F of midazolam and caffeine
Up to 72 hours post midazolam and caffeine dose

midazolam and caffeine pharmacokinetic parameter

AUClast of digoxin and rosuvastatin
Up to 240 hours post digoxin and rosuvastatin dose

digoxin and rosuvastatin pharmacokinetics parameters

AUCinf of digoxin and rosuvastatin
Up to 240 hours post digoxin and rosuvastatin dose

digoxin and rosuvastatin pharmacokinetics parameters

Lambda_z of digoxin and rosuvastatin
Up to 240 hours post digoxin and rosuvastatin dose

digoxin and rosuvastatin pharmacokinetics parameters

Cmax of digoxin and rosuvastatin
Up to 240 hours post digoxin and rosuvastatin dose

digoxin and rosuvastatin pharmacokinetics parameters

Tmax of digoxin and rosuvastatin
Up to 240 hours post digoxin and rosuvastatin dose

digoxin and rosuvastatin pharmacokinetics parameters

T1/2 of digoxin and rosuvastatin
Up to 240 hours post digoxin and rosuvastatin dose

digoxin and rosuvastatin pharmacokinetics parameters

CL/F of digoxin and rosuvastatin
Up to 240 hours post digoxin and rosuvastatin dose

digoxin and rosuvastatin pharmacokinetics parameters

Vz/F of digoxin and rosuvastatin
Up to 240 hours post digoxin and rosuvastatin dose

digoxin and rosuvastatin pharmacokinetics parameters

AUClast of INC280
Up to 72 hours post-dose

INC280 pharmacokinetic parameters

AUCinf of INC280
Up to 72 hours post-dose

INC280 pharmacokinetic parameters

Cmax of INC280
Up to 72 hours post-dose

INC280 pharmacokinetic parameters

Tmax of INC280
Up to 72 hours post-dose

INC280 pharmacokinetic parameters

T1/2 of INC280
Up to 72 hours post-dose

INC280 pharmacokinetic parameters

CL/F of INC280
Up to 72 hours post-dose

INC280 pharmacokinetic parameters

Vz/F of INC280
Up to 72 hours post-dose

INC280 pharmacokinetic parameters

Incidence rate of dose-limiting toxicities and adverse events
2 years
Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part
4 weeks

Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.

Secondary Endpoints

Phase Ib and II: Number of Participants With Adverse Events (AEs)
Up to 421 weeks
Phase Ib and II: Number of Participants With Serious Adverse Events (SAEs)
Up to 421 weeks
Phase Ib and II: Number of Patients With Dose Reductions of INC280 by Dose Level
Up to 417 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INC280 100 mg Cap QD Phase IbEXPERIMENTALcap=capsule; QD=once daily
INC280 200 mg Cap QD Phase IbEXPERIMENTALcap=capsule; QD=once daily
INC280 400 mg Cap QD Phase IbEXPERIMENTALcap=capsule; QD=once daily
INC280 800 mg Cap QD Phase IbEXPERIMENTALcap=capsule; QD=once daily
INC280 200 mg Cap BID Phase IbEXPERIMENTALcap=capsule; BID=twice daily
INC280 400 mg Cap BID Phase IbEXPERIMENTALcap=capsule; BID=twice daily
INC280 600 mg Cap BID Phase IbEXPERIMENTALcap=capsule; BID=twice daily
INC280 200 mg Tab BID Phase IbEXPERIMENTALtab=tablet; BID=twice daily
INC280 400 mg Tab BID Phase IbEXPERIMENTALtab=tablet; BID=twice daily
INC280 400 mg Cap BID Phase IIEXPERIMENTALcap=capsule; BID=twice daily
INC280 400 mg Tab BID Phase IIEXPERIMENTALtab=tablet; BID=twice daily
INC280EXPERIMENTAL -
Normal hepatic functionEXPERIMENTALSubjects with normal hepatic function
Mild hepatic impairmentEXPERIMENTALSubjects with mild hepatic impairment
Moderate hepatic impairmentEXPERIMENTALSubjects with moderate hepatic impairment
Severe hepatic impairmentEXPERIMENTALSubjects with severe hepatic impairment

Interventions

NameTypeDescription
INC280DRUGDuring Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.
GefitinibDRUGGefitinib 250 mg taken once daily
MidazolamDRUG -
CaffeineDRUG -
digoxinDRUG -
rosuvastatinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

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 ...

Countries:AustraliaBelgiumChinaFranceGermanyIsraelItalyJapanNetherlandsSingaporeSouth KoreaSpainTaiwanThailandUnited StatesAustriaDenmarkSwedenUnited KingdomBulgariaCzechiaGreeceCanadaHong KongNorway
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about INC280

What is Capmatinib used for?

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.

What does Capmatinib target?

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.

Who makes Capmatinib?

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.

What phase is Capmatinib in?

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.

What clinical trials is Capmatinib in?

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.

Is Capmatinib the same as INC280?

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.