A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

This study is currently recruiting participants.
Verified April 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01004224
First received: October 27, 2009
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Advanced Solid Tumors With FGFR1 Amplication,
Advanced Solid Tumors With FGFR2 Amplication,
Advanced Solid Tumors With FGFR3 Mutation
Drug: BGJ398
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the safety and tolerability of the compound at the RPTD [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetic profiles of the drug including known pharmacologically active metabolites [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
  • To evaluate the pharmacodynamic effect of the drug. [ Time Frame: 23 months ] [ Designated as safety issue: Yes ]
  • To assess any preliminary anti-tumor activity. [ Time Frame: 23 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: December 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGJ398 Drug: BGJ398

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004224

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, California
City of Hope National Medical Center COH Withdrawn
Duarte, California, United States, 91010-3000
University of California at Los Angeles Div. of Hematology/Oncology Completed
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Dept. of Anschutz Cancer (3) Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital Mass Gen 2 Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6) Completed
Detroit, Michigan, United States, 48201
United States, Pennsylvania
University of Pittsburgh Cancer Institute HIllman Cancer Center Terminated
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
The West Clinic West Clin Completed
Memphis, Tennessee, United States, 38120
Sarah Cannon Research Institute SC Active, not recruiting
Nashville, Tennessee, United States, 37203
Belgium
Novartis Investigative Site Withdrawn
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site Completed
Toronto, Ontario, Canada, M5G 2M9
France
Novartis Investigative Site Recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Not yet recruiting
Marseille, France, 13273
Novartis Investigative Site Not yet recruiting
Montellier cedex 5, France, 34298
Novartis Investigative Site Recruiting
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site Not yet recruiting
Suresnes, France, 92150
Novartis Investigative Site Recruiting
Toulouse Cedex 3, France, 31052
Novartis Investigative Site Recruiting
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Köln, Germany, 50924
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1066 CX
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01004224     History of Changes
Other Study ID Numbers: CBGJ398X2101, 2009-010876-73
Study First Received: October 27, 2009
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration
The Netherlands: The Medicines Evaluation Board (MEB)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Agence française de sécurité sanitaire des produits de santé (Afssaps)
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Canada: Health Canada

Keywords provided by Novartis:
advanced solid tumors
BGJ398
FGFR
kinase inhibitor
advanced solid malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014