A Phase I Study of Oral BGJ398 in Asian Patients

Novartis

Status and phase: Completed; Phase 1

Conditions: Tumor With Alterations of the FGF-R

Treatments: Drug: BGJ398

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697605

CBGJ398X1101

Details and patient eligibility

About

This study will evaluate safety and tolerability to determine the Maximum tolerated dose (MTD) and/or Recommended dose (RD).

Full description

This is a multi-center, open label, dose finding, phase I study of oral single agent BGJ398, administered on a continuous once and/or twice daily schedule.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with advanced solid tumors with FGF-R alteration
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate organ function

Exclusion criteria

• Patients with untreated and/or symptomatic metastatic Central Nerve System (CNS) disease
• Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

BGJ398

Experimental group

Description:

Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease.

Treatment:

Drug: BGJ398