A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Completed · Phase 1

Conditions studied: Advanced 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

In brief

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

Key facts

Study ID

NCT01004224

Run by

Novartis Pharmaceuticals

People needed

208

Starts

2009-12-11

Expected to finish

2018-10-08

Last updated by the study team

2019-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Duarte, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• University of Colorado Dept. of Anschutz Cancer (3) — Aurora, Colorado, United States
• Novartis Investigative Site — New Haven, Connecticut, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Memorial Sloan Kettering Cancer Center Onc. Dept.. — New York, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital Onc Dept — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Memphis, Tennessee, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Salt Lake City, Utah, United States
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Bordeaux, France
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Montpellier, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Saint-Herblain Cédex, France
• Novartis Investigative Site — Suresnes, France

Full record on ClinicalTrials.gov

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