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

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumor

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part

Outcome Description:

Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

February 2012

Completion Date:

March 2015

Related Keywords:

  • Advanced Solid Tumor
  • c-MET
  • Advanced solid tumor
  • Neoplasms