A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01546428

Enrollment

Registered

2012-03-07

Start date

2012-02-29

Completion date

2016-01-31

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

Keywords

c-MET, Advanced solid tumor

Brief summary

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

Interventions

DRUGINC280

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Incidence and severity of adverse events and serious adverse events, changes in laboratory values	4 months	Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.
Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2	1 month	Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months.
Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM	4 months	Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026