A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
18 Years
N/A
Both
Tumor With Alterations of the FGF-R
Trial Information
A Phase I Study of Oral BGJ398 in Asian Patients With Advanced Solid Tumor Having Alterations of the FGF-R Pathway
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence rate and category of dose limiting toxicities (DLTs)
Outcome Description:
Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
Outcome Time Frame:
First cycle of 28 days
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
CBGJ398X1101
NCT ID:
NCT01697605
Start Date:
February 2012
Completion Date:
March 2016
Related Keywords:
- Tumor With Alterations of the FGF-R
- Phase I, open-label, dose escalation, BGJ398, Japanese, Asian, FGF-R
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