In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overPharmaceutical / IndustryCTKI258A2211
2011-000266-35, NCT01379534

Trial Description

Summary

This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.

Eligibility Criteria

Inclusion Criteria:

  • Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy)
  • Female patients ≥ 18 years old
  • Documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  • At least one measurable lesion as per RECIST

Exclusion Criteria:

  • Previous treatment with an FGFR inhibitor
  • More than one line of treatment for advanced or metastatic disease
  • Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors
  • Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery
  • Known central nervous system (CNS) metastases
  • Malignancy within 3 years of study enrollment Other protocol-defined inclusion/exclusion criteria may apply

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis PharmaceuticalsStudy Director

Novartis PharmaceuticalsPh: 1-888-669-6682

Trial Sites

U.S.A.
Alabama
  Mobile
 University of South Alabama Mitchell Cancer Institute
 Mary Langham Ph: 251-445-9866
  Email: mlangham@usouthal.edu
 Rodney P RocconiPrincipal Investigator
California
  Fullerton
 St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center
 Gary Fields Ph: 714-446-5804
  Email: GFields@mednet.ucla.edu
 William LawlerPrincipal Investigator
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Rose Estrada Ph: 310-423-6595
  Email: Rose.Estrada@cshs.org
 Bobbie Jo Y. RimelPrincipal Investigator
 University of California Los Angeles Medical Center
 Manuel Carmona Ph: 310-794-6913
  Email: mcarmona@mednet.ucla.edu
 Gottfried KonecnyPrincipal Investigator
 USC/Norris Comprehensive Cancer Center and Hospital
 Shirley Sian Ph: 323-865-0452
  Email: shirley.sian@med.usc.edu
 Agustin GarciaPrincipal Investigator
  Santa Maria
 Central Coast Medical Oncology Corporation
 Contact Person Ph: 805-739-3724
 Robert DichmannPrincipal Investigator
Colorado
  Greenwood Village
 Rocky Mountain Cancer Centers - Greenwood Village
 Mary Rigden Ph: 303-285-5081
  Email: mary.rigden@usoncology.com
 Ling MaPrincipal Investigator
Connecticut
  New Haven
 Yale Cancer Center
 Michele Montagna Ph: 203-785-6398
  Email: michele.montagna@yale.edu
 Alessandro SantinPrincipal Investigator
Florida
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Deborah Sams Ph: 407-303-2091
  Email: Deborah.Sams@FLHOSP.ORG
 Neil FinklerPrincipal Investigator
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Carol Kulesavage Ph: 317-274-0757
  Email: ckulesav@iupui.edu
 Daniela MateiPrincipal Investigator
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Jessica Janecek Ph: 319-356-2015
  Email: jessica-janecek@uiowa.edu
 David BenderPrincipal Investigator
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Llazar M Cuko Ph: 617-632-2166
  Email: lcuko@partners.org
 Neil HorowitzPrincipal Investigator
Nebraska
  Lincoln
 Southeast Nebraska Cancer Center
 Sarah Mayo Ph: 402-327-7363
  Email: sarahm@leadingcancercare.com
 Steven DunderPrincipal Investigator
New Jersey
  Morristown
 Morristown Memorial Hospital SC
 Nelli Savkina Ph: 973-971-5235
  Email: nelli.savkina@atlantichealth.org
 Brian SlomovitzPrincipal Investigator
North Carolina
  Asheville
 Hope A Women's Cancer Center
 Ruth Gonzalez Ph: 828-670-8403
  Email: RNGonzalez@mednet.ucla.edu
 Timothy J VanderkwaakPrincipal Investigator
  Durham
 Duke Cancer Institute
 Elizabeth Bennett Ph: 919-681-9777
  Email: elizabeth.bennett2@dm.duke.edu
 Paula LeePrincipal Investigator
South Carolina
  Greenville
 Cancer Centers of the Carolinas SC-1
 Alexis Kelly
  Email: alexis.kelly@usoncology.com
 David Jeffery GriffinPrincipal Investigator
Tennessee
  Memphis
 West Clinic - East Memphis
 Mariesha Williams Ph: 901-683-0055
  Email: mawilliams@westclinic.com
 Todd TillmannsPrincipal Investigator
  Nashville
 Vanderbilt-Ingram Cancer Center
 Katie C. Lyons Ph: 615-936-5786
  Email: katie.lyons@Vanderbilt.Edu
 Marta Ann CrispensPrincipal Investigator
Texas
  Bedford
 Texas Oncology, P.A. Austin
 Liela Terada Ph: 512-421-4163
  Email: leila.terada@usoncology.com
 Michael TenerielloPrincipal Investigator
 Texas Oncology, P.A. Tex Onc (3)
 Autumn Potter Ph: 817-359-9033
  Email: autumn.potter@usoncology.com
 Mark MessingPrincipal Investigator
  Fort Worth
 Texas Oncology, P.A. SC
 Karen Haas
  Email: karen.haas@usoncology.com
 Noelle ClovenPrincipal Investigator
  San Antonio
 South Texas Oncology and Hematology, PA South Tex Onc
 Crystal Castillo Ph: 210-593-2572
  Email: crystal.castillo@start.stoh.com
 Allan WhitePrincipal Investigator
Virginia
  *see Various Departments*
 Virginia Oncology Associates VOA - Lake Wright
 Alison Payne Ph: 757-213-5637
  Email: alison.payne@usoncology.com
 Michael McCollumPrincipal Investigator
Washington
  Spokane
 Cancer Care Northwest SC
 Audrey Grayhek Ph: 509-228-1083
  Email: audrey.grayhek@ccnw.net
 Melanie BergmanPrincipal Investigator
Brazil
  Belo Horizonte
 Novartis Investigative Site
  Porto Alegre
 Novartis Investigative Site
Sao Paulo
  Ribeirao Preto
 Novartis Investigative Site
Italy
  Candiolo
 Novartis Investigative Site
  Genova
 Novartis Investigative Site
  Milano
 Novartis Investigative Site
  Monza
 Novartis Investigative Site
  Pisa
 Novartis Investigative Site
  Roma
 Novartis Investigative Site
New Zealand
  Grafton, Auckland
 Novartis Investigative Site
Spain
  Barcelona
 Novartis Investigative Site
  Cordoba
 Novartis Investigative Site
  Majadanonda
 Novartis Investigative Site
  Málaga
 Novartis Investigative Site
  Murcia
 Novartis Investigative Site
  Oviedo
 Novartis Investigative Site
  Sabadell
 Novartis Investigative Site
United Kingdom
  Glasgow
 Novartis Investigative Site
  Leeds
 Novartis Investigative Site
  London
 Novartis Investigative Site
  Nottingham
 Novartis Investigative Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01379534
ClinicalTrials.gov processed this data on March 13, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top