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

Novartis Pharmaceuticals44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor

Interventions

INC280DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Fukuoka, Japan

Outcomes

Primary Outcomes

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

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

Time frame: 4 weeks

Secondary Outcomes

Incidence and severity of adverse events and serious adverse events, changes in laboratory values

Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.

Time frame: 4 months

Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2

Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months.

Time frame: 1 month

Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM

Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM

Time frame: 4 months

Data from ClinicalTrials.gov

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