West Cancer Center

MOLECULARLY TARGETED: Metastatic; >/= 2nd line; FGFR mutation; "SIGNATURE CBGJ398XUS04"

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 6- BGJ398 for patients with tumors with FGFR genetic abnormalities

Title

Novartis CBGJ398XUS04

Study Title

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 6- BGJ398 for patients with tumors with FGFR genetic abnormalities

Site Link

NCT02160041

Malignancy

y- breast, lung, melanoma, prostate, colorectal, head and neck, gastric, renal, leukemia, lymphoma, sarcoma, ovarian

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

>/= 2nd line

Investigational Agent

BGJ398

Drug Class

FGFR inhibitor

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02160041

Key Eligibility Criteria Details

Must have FGFR gene alteration as measured in CLIA-certified lab
None of the following malignancies:
Bladder cancer (urothelial)
Cholangiocarcinoma
Endometrial cancer
Glioblastoma multiforme (GBM)
Received at least 1 prior line of therapy
No standard therapy expected to result in durable remission
ECOG PS 0-1
No CNS disease
No acute/chronic pancreatitis
No impared cardiac function
No corneal or retinal disorder
No other cancer within 3 years
_

Objective

Primary- Clinical Benefit Rate; Secondary- ORR, PFS, OS, DoR, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

FGFR genetic alteration

Dosing Frequency

BGJ398 125mg PO qday 3 wks on/ 1 wk off

Control Agents

N/A

Study Protocol

Randomized