Clinical trial · Interventional
A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
NCT01546428CI-TRIAL-00048976completedPhase 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)
INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
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 (1)
- measure
- Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part
- timeFrame
- 4 weeks
- description
- Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.
Secondary outcomes (3)
- measure
- Incidence and severity of adverse events and serious adverse events, changes in laboratory values
- timeFrame
- 4 months
- description
- Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 * Good organ (hepatic, kidney, BM) function at screening/baseline visit. Exclusion criteria: * Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280. * Undergone a bone marrow or solid organ transplant. * Women who are pregnant or breast feeding. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.