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

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: INC280

Study type: Interventional

Funder types: Industry

Identifiers

NCT01546428

CINC280X1101

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

INC280

Experimental group

Treatment:

Drug: INC280