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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

October 27, 2009
October 31, 2014
December 2009
June 2016   (final data collection date for primary outcome measure)
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 ]
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: 7 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01004224 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To characterize the safety and tolerability of the compound at the RPTD [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetic profiles of the drug including known pharmacologically active metabolites [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
  • To evaluate the pharmacodynamic effect of the drug. [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
  • To assess any preliminary anti-tumor activity. [ Time Frame: 14 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
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. The study will also investigate preliminary anti-tumor activity of the compound in treated patients.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Experimental: BGJ398
Intervention: Drug: BGJ398
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
190
June 2016
June 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Singapore,   Spain,   Taiwan,   Thailand,   Turkey
 
NCT01004224
CBGJ398X2101, 2009-010876-73
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP