Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01004224
Other study ID # CBGJ398X2101
Secondary ID 2009-010876-73
Status Completed
Phase Phase 1
First received
Last updated
Start date December 11, 2009
Est. completion date October 8, 2018

Study information

Verified date October 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date October 8, 2018
Est. primary completion date October 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3
  • Advanced Solid Tumors With FGFR1 Amplication
  • Advanced Solid Tumors With FGFR2 Amplication
  • Advanced Solid Tumors With FGFR3 Mutation
  • Bladder Cancer With FGFR3 Mutation or Fusion
  • Neoplasms
  • Squamous Lung Cancer With FGFR1 Amplification
  • Urinary Bladder Neoplasms

Intervention

Drug:
BGJ398


Locations

Country Name City State
Australia Novartis Investigative Site Heidelberg Victoria
Austria Novartis Investigative Site Vienna
France Novartis Investigative Site Bordeaux Cedex
France Novartis Investigative Site Lyon Cedex
France Novartis Investigative Site Marseille
France Novartis Investigative Site Montpellier Cedex 5
France Novartis Investigative Site Paris
France Novartis Investigative Site Saint-Herblain Cédex
France Novartis Investigative Site Suresnes
France Novartis Investigative Site Toulouse Cedex 9
France Novartis Investigative Site Villejuif Cedex
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Koeln Nordrhein-Westfalen
Germany Novartis Investigative Site Marburg
Israel Novartis Investigative Site Ramat Gan
Israel Novartis Investigative Site Tel Aviv
Italy Novartis Investigative Site Meldola FC
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Amsterdam
Singapore Novartis Investigative Site Singapore
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Sevilla Andalucia
Spain Novartis Investigative Site Valencia Comunidad Valenciana
Taiwan Novartis Investigative Site Taipei
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Chiang Mai
Turkey Novartis Investigative Site Izmir
United States University of Colorado Dept. of Anschutz Cancer (3) Aurora Colorado
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Detroit Michigan
United States Novartis Investigative Site Duarte California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Memphis Tennessee
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center Onc. Dept.. New York New York
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Onc Dept Philadelphia Pennsylvania
United States Novartis Investigative Site Pittsburgh Pennsylvania
United States Novartis Investigative Site Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Singapore,  Spain,  Taiwan,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 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 23 months
Secondary 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) 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 23 months
Secondary To determine the pharmacokinetic (PK) profiles of oral BGJ398 Time vs. concentration profiles, PK parameters of BGJ398 and known active metabolite(s). 23 months
Secondary To evaluate the pharmacodynamic effect of the drug. Pre- vs. post treatment serial changes in FGF23 plasma levels (not done for patients enrolled to expansion Arm 4) 23 months
Secondary Assess preliminary anti-tumor activity for patients not in Arm 4. Overall tumor response rate (ORR) and PFS assessed by investigator per RECIST 23 months

External Links