A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Plain-language summary

This study evaluates the drug BGJ398 at increasing doses in patients with advanced solid tumors carrying FGFR1 or FGFR2 gene amplification or FGFR3 mutation, for whom no standard treatment remains. It included patients with confirmed advanced tumors. It was a Phase 1 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Novartis Pharmaceuticals

Intervention

BGJ398

Start date

12/11/2009

Estimated completion

10/8/2018

Countries

United States, Australia, Austria, France, Germany, Israel, Italy, Netherlands, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Related genes

Locations

• Duarte, United States
• Los Angeles, United States
• Los Angeles, United States
• Aurora, United States
• New Haven, United States
• Boston, United States
• Detroit, United States
• New York, United States
• New York, United States
• Columbus, United States
• Philadelphia, United States
• Philadelphia, United States
• Pittsburgh, United States
• Memphis, United States
• Nashville, United States
• Salt Lake City, United States
• Heidelberg, Australia
• Vienna, Austria
• Bordeaux, France
• Lyon, France
• Marseille, France
• Montpellier, France
• Paris, France
• Saint-Herblain Cédex, France
• Suresnes, France
• Toulouse, France
• Villejuif, France
• Cologne, Germany
• Essen, Germany
• Hanover, Germany
• Marburg, Germany
• Ramat Gan, Israel
• Tel Aviv, Israel
• Meldola, Italy
• Amsterdam, Netherlands
• Amsterdam, Netherlands
• Singapore, Singapore
• Seoul, South Korea
• Seoul, South Korea
• Seville, Spain

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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