Search for more clinical trials
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
Conditions
Advanced Solid Tumors With Alterations of FGFR1, 2 and/or 3; - Squamous Lung Cancer With FGFR1 Amplification; - Bladder Cancer With FGFR3 Mutation or Fusion
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
advanced solid tumors, lung cancer, bladder cancer, BGJ398, FGFR, kinase inhibitor, advanced solid malignancies
Study Type
Interventional
Study Phase
Phase 1
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: BGJ398
Type: Drug
Overall Status
Recruiting
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. The study will also investigate preliminary anti-tumor activity of the compound in treated patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 chemotherapy (not including neoadjuvant or adjuvant) for advanced/metastatic disease for UCC patients. UCC patients with more than 2 prior lines of systemic chemotherapy may be considered for inclusion on a case by case basis after discussion with Novartis. Prior immunotherapy or biological therapy is permitted and does not count towards the 2 prior lines.
- Must be measurable disease for UCC patients
- A representative tumor sample must be available for molecular testing. The biopsy sample must be obtained from an advanced, invasive or metastatic lesion.
- 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 or retinal 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.
- 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 chemotherapy (not including neoadjuvant or adjuvant) for advanced/metastatic disease for UCC patients. UCC patients with more than 2 prior lines of systemic chemotherapy may be considered for inclusion on a case by case basis after discussion with Novartis. Prior immunotherapy or biological therapy is permitted and does not count towards the 2 prior lines.
- Must be measurable disease for UCC patients
- A representative tumor sample must be available for molecular testing. The biopsy sample must be obtained from an advanced, invasive or metastatic lesion.
- 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 or retinal 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.
Locations
City of Hope National Medical Center COH
Duarte, California, United States
City of Hope National Medical Center Oncology Department
Status: Withdrawn
Duarte, California, United States
University of California San Diego Onc Dept
Status: Recruiting
Contact: Kandice Smith - 626-218-1578 - Ksmith@coh.org
La Jolla, California, United States
University of California at Los Angeles Div. of Hematology/Oncology
Status: Recruiting
Contact: Audrey Dinh - 858-822-5374 - Adinh@ucsd.edu
Los Angeles, California, United States
USC/Kenneth Norris Comprehensive Cancer Center Onc Dept.
Status: Completed
Los Angeles, California, United States
University of Colorado Dept. of Anschutz Cancer (3)
Status: Recruiting
Contact: Lagrimas Ilagan - ilagan_l@med.usc.edu
Aurora, Colorado, United States
Yale University School of Medicine Onc Dept
Status: Active, not recruiting
New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center & Research Institute Dept of Onc
Status: Recruiting
Contact: Jerri Tomassi - 203-737-8367 - Geraldine.tomassi@yale.edu
Tampa, Florida, United States
Crescent City Research Consortium, LLC Onc Dept
Status: Recruiting
Contact: Jesse S. Mocha - 813-745-4616 - jesse.mocha@moffitt.org
Metairie, Louisiana, United States
Massachusetts General Hospital Mass Gen 2
Status: Recruiting
Contact: Nicole Krohn - 504-885-8220 - Nicole.Krohn@touro.com
Boston, Massachusetts, United States
Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)
Status: Active, not recruiting
Detroit, Michigan, United States
Montefiore Medical Center OncDept
Status: Recruiting
Contact: Karen Forman - 313-576-9373 - formank@karmanos.org
Bronx, New York, United States
Memorial Sloan Kettering Cancer Center Onc. Dept..
Status: Recruiting
Contact: Christina Garcia-Miller - 718-405-8515 - crgarcia@montefiore.org
New York, New York, United States
Mount Sinai School of Medicine Onc Dept.
Status: Recruiting
Contact: Dean Bajorin - 646-422-4333
New York, New York, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital Onc Dept..
Status: Recruiting
Contact: Katrina Watson - 212-824-7319 - katrina.watson@mssm.edu
Columbus, Ohio, United States
Thomas Jefferson University Hospital Onc Dept
Status: Recruiting
Contact: Adam Norris - 614-688-8836 - adam.norris@osumc.edu
Philadelphia, Pennsylvania, United States
University of Pennsylvania Medical Center Onc Dept
Status: Recruiting
Contact: Alicia Peluso - 215-955-9244 - alicia.peluso@jefferson.edu
Philadephia, Pennsylvania, United States
University of Pittsburgh Cancer Institute HIllman Cancer Center
Status: Recruiting
Contact: Luis A Aguilar - 215-349-8498 - Luis.Aguilar@uphs.upenn.edu
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Oncology Dept
Status: Terminated
Charleston, South Carolina, United States
The West Clinic West Clin
Status: Withdrawn
Memphis, Tennessee, United States
Sarah Cannon Research Institute SC
Status: Completed
Nashville, Tennessee, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)
Status: Active, not recruiting
Houston, Texas, United States
University of Utah / Huntsman Cancer Institute Huntsman
Status: Withdrawn
Salt Lake City, Utah, United States
Novartis Investigative Site
Status: Recruiting
Contact: Whitney Bevans - 801-585-0443 - whitney.bevans@hci.utah.edu
Heidelberg, Victoria, Australia
Novartis Investigative Site
Status: Recruiting
Linz, Austria
Novartis Investigative Site
Status: Recruiting
Vienna, Austria
Novartis Investigative Site
Status: Recruiting
Leuven, Belgium
Novartis Investigative Site
Status: Withdrawn
Toronto, Ontario, Canada
Novartis Investigative Site
Status: Completed
Bordeaux Cedex, France
Novartis Investigative Site
Status: Recruiting
Lille Cedex, France
Novartis Investigative Site
Status: Withdrawn
Lyon Cedex, France
Novartis Investigative Site
Status: Recruiting
Marseille, France
Novartis Investigative Site
Status: Recruiting
Montpellier Cedex 5, France
Novartis Investigative Site
Status: Recruiting
Paris, France
Novartis Investigative Site
Status: Not yet recruiting
Saint-Herblain Cédex, France
Novartis Investigative Site
Status: Recruiting
Suresnes, France
Novartis Investigative Site
Status: Recruiting
Toulouse Cedex 9, France
Novartis Investigative Site
Status: Recruiting
Villejuif Cedex, France
Novartis Investigative Site
Status: Recruiting
Essen, Germany
Novartis Investigative Site
Status: Recruiting
Göttingen, Germany
Novartis Investigative Site
Status: Not yet recruiting
Hannover, Germany
Novartis Investigative Site
Status: Not yet recruiting
Köln, Germany
Novartis Investigative Site
Status: Recruiting
Marburg, Germany
Novartis Investigative Site
Status: Recruiting
Haifa, Israel
Novartis Investigative Site
Status: Recruiting
Petach Tikva, Israel
Novartis Investigative Site
Status: Not yet recruiting
Ramat Gan, Israel
Novartis Investigative Site
Status: Recruiting
Tel-Aviv, Israel
Novartis Investigative Site
Status: Recruiting
Ancona, AN, Italy
Novartis Investigative Site
Status: Recruiting
Meldola, FC, Italy
Novartis Investigative Site
Status: Recruiting
Milano, MI, Italy
Novartis Investigative Site
Status: Recruiting
Milano, MI, Italy
Novartis Investigative Site
Status: Recruiting
Milano, MI, Italy
Novartis Investigative Site
Status: Recruiting
Terni, TR, Italy
Novartis Investigative Site
Status: Recruiting
Seoul, Korea, Korea, Republic of
Novartis Investigative Site
Status: Recruiting
Seoul, Korea, Korea, Republic of
Novartis Investigative Site
Status: Recruiting
Seoul, Korea, Korea, Republic of
Novartis Investigative Site
Status: Recruiting
Amsterdam, Netherlands
Novartis Investigative Site
Status: Recruiting
Amsterdam, Netherlands
Novartis Investigative Site
Status: Recruiting
Singapore, Singapore
Novartis Investigative Site
Status: Recruiting
Sevilla, Andalucia, Spain
Novartis Investigative Site
Status: Recruiting
Barcelona, Catalunya, Spain
Novartis Investigative Site
Status: Recruiting
Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site
Status: Recruiting
Barcelona, Spain
Novartis Investigative Site
Status: Recruiting
Madrid, Spain
Novartis Investigative Site
Status: Recruiting
Madrid, Spain
Novartis Investigative Site
Status: Recruiting
Madrid, Spain
Novartis Investigative Site
Status: Recruiting
Taipei, Taiwan
Novartis Investigative Site
Status: Recruiting
Bangkok, Thailand
Novartis Investigative Site
Status: Recruiting
Chiang Mai, Thailand
Novartis Investigative Site
Status: Recruiting
Izmir, Turkey
Status: Recruiting
Start Date
December 2009
Completion Date
June 2016
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page