Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03040973 | Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone | PHASE2 | ACTIVE NOT_RECRUITING | 29 | — | — | Aug 23, 2017 | Jul 30, 2027 | Apr 2, 2026 | 15 | United States, Belgium +9 |
Collection of adverse events and serious adverse events at every visit. Safety assessment will be performed and include local laboratory test monitoring in addition to local standard of care assessments.
| Arm | Type | Description |
|---|---|---|
| Capmatinib | EXPERIMENTAL | Starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted. |
| Capmatinib + Nazartinib | EXPERIMENTAL | Starting dose of the study treatment for patients should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted. |
| Capmatinib + Gefitinib | EXPERIMENTAL | Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted. |
| Capmatinib + Osimertinib | EXPERIMENTAL | Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted. |
| Name | Type | Description |
|---|---|---|
| Capmatinib | DRUG | Tablet for oral use; 150 mg, 200 mg; twice a day |
| Nazartinib | DRUG | Capsule for oral use; 25 mg, 50 mg; once a day |
| Gefitinib | DRUG | tablets for oral use; 250mg; once a day |
| Osimertinib | DRUG | Tablets for oral use; 40 mg, 80 mg; once a day. |
Inclusion criteria: 1. Participant is currently receiving capmatinib treatment (within Novartis-sponsored study which is eligible and approved to transition participants to rollover study) as single agent or in combination or is receiving a combination treatment alone. This includes all participant...