Clinical trial · Interventional
A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.
A Multicenter, Open Label, Phase 1 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INC280 Tablet Formulation With Food in Patients With cMET Dysregulated Advanced Solid Tumors.
NCT02925104CI-TRIAL-00048963completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| cMET Dysegulation Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INC280 | Drug | Capmatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INC280
- interventionNames
- Drug: INC280
Primary outcomes (7)
- measure
- Incidence of Dose limiting toxiticites (DLTs)
- timeFrame
- During the first 28 days on INC280 treatment; cycle = 21 days
- measure
- Frequency of DLTs
- timeFrame
- During the first 28 days on INC280 treatment
- measure
- Category of DLTs
- timeFrame
- During the first 28 days on INC280 treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * cMET dysregulated advanced solid tumor * At least one measurable lesion as defined by RECIST 1.1 * Recovered from all toxicities related to prior anti-cancer therapies to grade ≤ 1 * Adequate organ function * ECOG performance status (PS) ≤ 1 Exclusion Criteria: * Prior treatment with crizotinib or any other cMET or HGF inhibitor * Known hypersensitivity to any of the excipients of INC280 * Symptomatic central nervous system (CNS) metastases who are neurologically unstable * Presence or history of a malignant disease other than the study related cancer * Clinically significant, uncontrolled heart diseases * Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities * Major surgery within 4 weeks prior to starting INC280 * Impairment of GI function * Patients receiving unstable or increasing doses of corticosteroids * Patients receiving treatment with any enzyme-inducing anticonvulsant * Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDMoreno V, Greil R, Yachnin J, Majem M, Wermke M, Arkenau HT, Basque JR, Nidamarthy PK, Kapoor S, Cui X, Giovannini M. Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors. Clin Ther. 2021 Jun;43(6):1092-1111. doi: 10.1016/j.clinthera.2021.04.006. Epub 2021 May 27. PMID 34053700