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

Novartis Pharmaceuticals4 sites in 2 countries208 target enrollmentDecember 11, 2009

ConditionsAdvanced Solid Tumors With Alterations of FGFR1, 2 and or 3 Squamous Lung Cancer With FGFR1 Amplification Bladder Cancer With FGFR3 Mutation or Fusion Advanced Solid Tumors With FGFR1 Amplication Advanced Solid Tumors With FGFR2 Amplication Advanced Solid Tumors With FGFR3 Mutation

InterventionsBGJ398

DrugsBGJ398

Overview

Phase: Phase 1
Intervention: BGJ398
Conditions: Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3
Sponsor: Novartis Pharmaceuticals
Enrollment: 208
Locations: 4
Primary Endpoint: Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

Registry

clinicaltrials.gov

Start Date

December 11, 2009

End Date

October 8, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
•Adequate bone marrow function
•Adequate hepatic and renal function
•Adequate cardiovascular function
•Contraception.
•For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
•For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period

Exclusion Criteria

•Patients with primary CNS tumor or CNS tumor involvement
•Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
•History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
•Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
•History or current evidence of cardiac arrhythmia and/or conduction abnormality
•Women who are pregnant or nursing.
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

BGJ398

Intervention: BGJ398

Outcomes

Primary Outcomes

Time Frame: 23 months

Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters

Secondary Outcomes

Assess preliminary anti-tumor activity for patients not in Arm 4.(23 months)
To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations)(23 months)
To determine the pharmacokinetic (PK) profiles of oral BGJ398(23 months)
To evaluate the pharmacodynamic effect of the drug.(23 months)