A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBGJ398

The study team can explain what participation involves.

Who it may be forAdvanced Solid Tumors With Alterations of FGFR1, 2 and or 3 · Squamous Lung Cancer With FGFR1 Amplification

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 4, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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What kind of study?Phase 1

Interventional

Where is it offered?50 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
Interventions being studied: Drug: BGJ398

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Novartis Investigative SiteDuarte, California
Novartis Investigative SiteLos Angeles, California
Novartis Investigative SiteLos Angeles, California
University of Colorado Dept. of Anschutz Cancer (3)Aurora, Colorado
Novartis Investigative SiteNew Haven, Connecticut
Novartis Investigative SiteBoston, Massachusetts
Novartis Investigative SiteDetroit, Michigan
Memorial Sloan Kettering Cancer Center Onc. Dept..New York, New York
Novartis Investigative SiteNew York, New York
Novartis Investigative SiteColumbus, Ohio
Novartis Investigative SitePhiladelphia, Pennsylvania
Thomas Jefferson University Hospital Onc DeptPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 4, 2019. Always confirm current availability with the study team.

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