CompletedPhase 1NCT01004224

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

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

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

StatusCompleted
PhasePhase 1
U.S. locations50
SponsorNovartis Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: BGJ398
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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

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

04
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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