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A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004224
First Posted: October 29, 2009
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
October 27, 2009
October 29, 2009
October 10, 2017
December 11, 2009
February 15, 2018   (Final data collection date for primary outcome measure)
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD) [ Time Frame: 23 months ]
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters
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 ]
Complete list of historical versions of study NCT01004224 on ClinicalTrials.gov Archive Site
  • To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations) [ Time Frame: 23 months ]
    overall response rate (ORR), as assessed by investigator per RECIST v 1.0; overall survival (OS), duration of response (DOR) and disease control rate (DCR) will be assessed
  • To determine the pharmacokinetic (PK) profiles of oral BGJ398 [ Time Frame: 23 months ]
    Time vs. concentration profiles, PK parameters of BGJ398 and known active metabolite(s).
  • To evaluate the pharmacodynamic effect of the drug. [ Time Frame: 23 months ]
    Pre- vs. post treatment serial changes in FGF23 plasma levels (not done for patients enrolled to expansion Arm 4)
  • Assess preliminary anti-tumor activity for patients not in Arm 4. [ Time Frame: 23 months ]
    Overall tumor response rate (ORR) and PFS assessed by investigator per RECIST
  • To characterize the safety and tolerability of the compound at the RPTD [ Time Frame: 7 months ]
  • To determine the pharmacokinetic profiles of the drug including known pharmacologically active metabolites [ Time Frame: 14 months ]
  • To evaluate the pharmacodynamic effect of the drug. [ Time Frame: 14 months ]
  • To assess any preliminary anti-tumor activity. [ Time Frame: 14 months ]
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
  • Advanced Solid Tumors With FGFR1 Amplication
  • Advanced Solid Tumors With FGFR2 Amplication
  • Advanced Solid Tumors With FGFR3 Mutation
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.
 
Active, not recruiting
208
February 15, 2018
February 15, 2018   (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
  • 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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Singapore,   Spain,   Taiwan,   Thailand,   Turkey,   United States
Belgium,   Canada
 
NCT01004224
CBGJ398X2101
2009-010876-73 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2017

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