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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors With FGFR1 Amplication,, Advanced Solid Tumors With FGFR2 Amplication,, Advanced Solid Tumors With FGFR3 Mutation

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose and thus the recommended phase II dose and schedule of single agent oral in patients with advance solid tumors

Outcome Time Frame:

23 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBGJ398X2101

NCT ID:

NCT01004224

Start Date:

December 2009

Completion Date:

December 2013

Related Keywords:

  • Advanced Solid Tumors With FGFR1 Amplication,
  • Advanced Solid Tumors With FGFR2 Amplication,
  • Advanced Solid Tumors With FGFR3 Mutation
  • advanced solid tumors
  • BGJ398
  • FGFR
  • kinase inhibitor
  • advanced solid malignancies
  • Neoplasms

Name

Location

University of Pittsburgh Cancer Institute Hillman Cancer CenterPittsburgh, Pennsylvania  15232
City of Hope National Medical Center COHDuarte, California  91010-3000
UCLA/ University of California Los Angeles Div. of Hematology/OncologyLos Angeles, California  90095
University of Colorado Dept. of Anschutz Cancer (3)Aurora, Colorado  80045
Massachusetts General Hospital Mass Gen 2Boston, Massachusetts  02114
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)Detroit, Michigan  48201
The West Clinic West ClinMemphis, Tennessee  38120
Sarah Cannon Research Institute SCNashville, Tennessee  37203