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.
Locations
City of Hope National Medical Center COH
Duarte, California, United States
Status: Withdrawn
City of Hope National Medical Center Oncology Department
Duarte, California, United States
Status: Recruiting
Contact: Kandice Smith - 626-218-1578 - Ksmith@coh.org
University of California San Diego Onc Dept
La Jolla, California, United States
Status: Recruiting
Contact: Audrey Dinh - 858-822-5374 - Adinh@ucsd.edu
University of California at Los Angeles Div. of Hematology/Oncology
Los Angeles, California, United States
Status: Completed
USC/Kenneth Norris Comprehensive Cancer Center Onc Dept.
Los Angeles, California, United States
Status: Recruiting
Contact: Lagrimas Ilagan - ilagan_l@med.usc.edu
University of Colorado Dept. of Anschutz Cancer (3)
Aurora, Colorado, United States
Status: Active, not recruiting
Yale University School of Medicine Onc Dept
New Haven, Connecticut, United States
Status: Recruiting
Contact: Jerri Tomassi - 203-737-8367 - Geraldine.tomassi@yale.edu
H. Lee Moffitt Cancer Center & Research Institute Dept of Onc
Tampa, Florida, United States
Status: Recruiting
Contact: Jesse S. Mocha - 813-745-4616 - jesse.mocha@moffitt.org
Crescent City Research Consortium, LLC Onc Dept
Metairie, Louisiana, United States
Status: Recruiting
Contact: Nicole Krohn - 504-885-8220 - Nicole.Krohn@touro.com
Massachusetts General Hospital Mass Gen 2
Boston, Massachusetts, United States
Status: Active, not recruiting
Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)
Detroit, Michigan, United States
Status: Recruiting
Contact: Karen Forman - 313-576-9373 - formank@karmanos.org
Montefiore Medical Center OncDept
Bronx, New York, United States
Status: Recruiting
Contact: Christina Garcia-Miller - 718-405-8515 - crgarcia@montefiore.org
Memorial Sloan Kettering Cancer Center Onc. Dept..
New York, New York, United States
Status: Recruiting
Contact: Dean Bajorin - 646-422-4333
Mount Sinai School of Medicine Onc Dept.
New York, New York, United States
Status: Recruiting
Contact: Katrina Watson - 212-824-7319 - katrina.watson@mssm.edu
Ohio State Comprehensive Cancer Center/James Cancer Hospital Onc Dept..
Columbus, Ohio, United States
Status: Recruiting
Contact: Adam Norris - 614-688-8836 - adam.norris@osumc.edu
Thomas Jefferson University Hospital Onc Dept
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Alicia Peluso - 215-955-9244 - alicia.peluso@jefferson.edu
University of Pennsylvania Medical Center Onc Dept
Philadephia, Pennsylvania, United States
Status: Recruiting
Contact: Luis A Aguilar - 215-349-8498 - Luis.Aguilar@uphs.upenn.edu
University of Pittsburgh Cancer Institute HIllman Cancer Center
Pittsburgh, Pennsylvania, United States
Status: Terminated
Medical University of South Carolina Oncology Dept
Charleston, South Carolina, United States
Status: Withdrawn
The West Clinic West Clin
Memphis, Tennessee, United States
Status: Completed
Sarah Cannon Research Institute SC
Nashville, Tennessee, United States
Status: Active, not recruiting
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)
Houston, Texas, United States
Status: Withdrawn
University of Utah / Huntsman Cancer Institute Huntsman
Salt Lake City, Utah, United States
Status: Recruiting
Contact: Whitney Bevans - 801-585-0443 - whitney.bevans@hci.utah.edu
Novartis Investigative Site
Heidelberg, Victoria, Australia
Status: Recruiting
Novartis Investigative Site
Linz, Austria
Status: Recruiting
Novartis Investigative Site
Vienna, Austria
Status: Recruiting
Novartis Investigative Site
Leuven, Belgium
Status: Withdrawn
Novartis Investigative Site
Toronto, Ontario, Canada
Status: Completed
Novartis Investigative Site
Bordeaux Cedex, France
Status: Recruiting
Novartis Investigative Site
Lille Cedex, France
Status: Withdrawn
Novartis Investigative Site
Lyon Cedex, France
Status: Recruiting
Novartis Investigative Site
Marseille, France
Status: Recruiting
Novartis Investigative Site
Montpellier Cedex 5, France
Status: Recruiting
Novartis Investigative Site
Paris, France
Status: Not yet recruiting
Novartis Investigative Site
Saint-Herblain Cédex, France
Status: Recruiting
Novartis Investigative Site
Suresnes, France
Status: Recruiting
Novartis Investigative Site
Toulouse Cedex 9, France
Status: Recruiting
Novartis Investigative Site
Villejuif Cedex, France
Status: Recruiting
Novartis Investigative Site
Essen, Germany
Status: Recruiting
Novartis Investigative Site
Göttingen, Germany
Status: Not yet recruiting
Novartis Investigative Site
Hannover, Germany
Status: Not yet recruiting
Novartis Investigative Site
Köln, Germany
Status: Recruiting
Novartis Investigative Site
Marburg, Germany
Status: Recruiting
Novartis Investigative Site
Haifa, Israel
Status: Recruiting
Novartis Investigative Site
Petach Tikva, Israel
Status: Not yet recruiting
Novartis Investigative Site
Ramat Gan, Israel
Status: Recruiting
Novartis Investigative Site
Tel-Aviv, Israel
Status: Recruiting
Novartis Investigative Site
Ancona, AN, Italy
Status: Recruiting
Novartis Investigative Site
Meldola, FC, Italy
Status: Recruiting
Novartis Investigative Site
Milano, MI, Italy
Status: Recruiting
Novartis Investigative Site
Milano, MI, Italy
Status: Recruiting
Novartis Investigative Site
Milano, MI, Italy
Status: Recruiting
Novartis Investigative Site
Terni, TR, Italy
Status: Recruiting
Novartis Investigative Site
Seoul, Korea, Korea, Republic of
Status: Recruiting
Novartis Investigative Site
Seoul, Korea, Korea, Republic of
Status: Recruiting
Novartis Investigative Site
Seoul, Korea, Korea, Republic of
Status: Recruiting
Novartis Investigative Site
Amsterdam, Netherlands
Status: Recruiting
Novartis Investigative Site
Amsterdam, Netherlands
Status: Recruiting
Novartis Investigative Site
Singapore, Singapore
Status: Recruiting
Novartis Investigative Site
Sevilla, Andalucia, Spain
Status: Recruiting
Novartis Investigative Site
Barcelona, Catalunya, Spain
Status: Recruiting
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain
Status: Recruiting
Novartis Investigative Site
Barcelona, Spain
Status: Recruiting
Novartis Investigative Site
Madrid, Spain
Status: Recruiting
Novartis Investigative Site
Madrid, Spain
Status: Recruiting
Novartis Investigative Site
Madrid, Spain
Status: Recruiting
Novartis Investigative Site
Taipei, Taiwan
Status: Recruiting
Novartis Investigative Site
Bangkok, Thailand
Status: Recruiting
Novartis Investigative Site
Chiang Mai, Thailand
Status: Recruiting
Novartis Investigative Site
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