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A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01004224
First received: October 27, 2009
Last updated: October 31, 2014
Last verified: October 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. The study will also investigate preliminary anti-tumor activity of the compound in treated patients.


Condition Intervention Phase
Advanced Solid Tumors With Alterations of FGFR1, 2 and/or 3;
Squamous Lung Cancer With FGFR1 Amplification;
Bladder Cancer With FGFR3 Mutation or Fusion
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 study drug 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 further assess any preliminary anti-tumor activity. [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • To assess preliminary anti-tumor activity of the compound in patients with advanced/metastatic urothelial cell carcinoma with FGFR3 genetic alterations [ 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
  • Patients with advanced/metastatic urothelial cell carcinoma (UCC) with FGFR3 mutations or gene fusions progressing after platinum-based chemotherapy or intolerant to platinum therapy or for whom platinum is contraindicated
  • No more than 2 prior lines of systemic therapy (including adjuvant) for advanced/metastatic disease for UCC patients
  • Must be measurable disease for UCC patients
  • A representative tumor sample must be available for molecular testing
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

  Show 67 Study Locations
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: October 31, 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
lung cancer
bladder cancer
BGJ398
FGFR
kinase inhibitor
advanced solid malignancies

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms
Urinary Bladder Neoplasms
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014