West Cancer Center

ADVANCED SOLID TUMORS: Phase 1; FGFR Positive; "CBGJ398"

A phase I, open-label, multi-center, dose escalation study of oral BGJ398, a pan FGF-R kinase inhibitor, in adult patients with advanced solid malignancies____

Title

Novartis CBGJ398X2101

Study Title

A phase I, open-label, multi-center, dose escalation study of oral BGJ398, a pan FGF-R kinase inhibitor, in adult patients with advanced solid malignancies____

Site Link

NCT01004224

Malignancy

z- Advanced Solid Tumors, Bladder Cancer, Squamous Lung Cancer

Stage

Stage 2

Disease Setting

Metastatic,�Palliative

Line Of Therapy

last (no further standard therapy),>3rd

Investigational Agent

BJG398

Drug Class

FGF-R (fibroblast growth factor- receptor) kinase inhibitor

Gary Tian, MD

Sponsor

Novartis

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

No CNS involvement. No current corneal disorder/keratophathy. Normal calcium/phosphate homeostasis, normal cardiac function (by echo/MUGA)

Key Eligibility Criteria Details

FGFR1�or FGFR2 amplification positive (+)
� � � � �or FGFR3 mutation positive__ (+)
No CNS involvement.�
No current corneal disorder/keratophathy.�
Normal calcium/phosphate homeostasis
Normal cardiac function (by echo/MUGA)__

Objective

_Primary. MTD of single agent BGJ398, Secondary a)PK profile b)effect on FGF23 plasma level c)assess any prelim anti-tumor activity, d) Safety and tolerability_

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

FGFR1�or FGFR2 amplification positive (+)or FGFR3 mutation positive__ (+)

Dosing Frequency

Control Agents

N/A

Study Protocol

Randomized