A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:December 11, 2009
End Date:October 8, 2018

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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

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


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
We found this trial at
16
sites
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Boston, Massachusetts 02118
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Boston, MA
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Columbus, Ohio 43205
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Columbus, OH
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Detroit, Michigan 48202
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Detroit, MI
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Duarte, California 91010
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Duarte, CA
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Heidelberg, Victoria 3084
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Heidelberg,
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Los Angeles, California 90095
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Los Angeles, CA
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Memphis, Tennessee 38120
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Memphis, TN
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Nashville, Tennessee 37205
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Nashville, TN
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New Haven, Connecticut
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New Haven, CT
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New York, New York 10021
Principal Investigator: Dean Bajorin
Phone: 646-422-4333
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New York, NY
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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New York, NY
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Philadelphia, Pennsylvania 19107
Principal Investigator: Jean Hoffman-Censits
Phone: 215-955-1661
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Philadelphia, PA
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15224
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Salt Lake City, Utah 84103
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Salt Lake City, UT
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