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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01610336 | A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment | PHASE2 | COMPLETED | 161 | — | — | Apr 5, 2012 | May 27, 2020 | Apr 8, 2021 | 31 | Australia, Belgium +12 |
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.
| 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 |
| 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 |
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 ...