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

This study is currently recruiting participants.
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01379534
First received: June 6, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Solid Tumors and Advanced Endometrial Cancer
Endometrial Cancer
Second-line Treatment
VEGF
Drug: TKI258
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Single-arm, Non-randomized, Multi-center Study to Evaluate the Efficacy of Oral TKI258 as Second-line Therapy in Patients With Either FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • the antitumor activity of TKI258, as measured by an 18-week progression free survival rate [ Time Frame: up to 18 weeks after the first dose of study drug ] [ Designated as safety issue: No ]
    The 18-week PFS is defined as the percentage of patients who do not have a progression event at week 18


Secondary Outcome Measures:
  • overall response rate (ORR) [ Time Frame: baseline and every 6 weeks until disease progression ] [ Designated as safety issue: No ]
    ORR is defined as percentage of patients with a best overall response of complete response (CR), partial response (PR) or progressive disease (PD)

  • disease control rate (DCR) [ Time Frame: baseline and every 6 weeks until disease progression ] [ Designated as safety issue: No ]
    DCR is defined as percentage of patients with a best overall response of CR, PR or stable disease (SD)

  • characterize the safety and tolerability of TKI258 [ Time Frame: up to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Safety will be measured in terms of incidence of adverse events, serious adverse events, changes from baseline in vital signs, laboratory test results, ECG and cardiac imaging


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKI258
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Drug: TKI258
Other Name: dovitinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379534

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama / Mitchell Cancer Institute Univ South Alabama Recruiting
Mobile, Alabama, United States, 36688
Contact: Mary Langham    251-445-9866    mlangham@usouthal.edu   
Principal Investigator: Rodney P Rocconi         
United States, California
St. Jude Heritage Medical Group St Jude Recruiting
Fullerton, California, United States, 92835
Contact: Gary Fields    714-446-5804    GFields@mednet.ucla.edu   
Principal Investigator: William Lawler         
University of California at Los Angeles UCLA 3 Recruiting
Los Angeles, California, United States, 90095
Contact: Manuel Carmona    310-794-6913    mcarmona@mednet.ucla.edu   
Principal Investigator: Gottfried Konecny         
USC/Kenneth Norris Comprehensive Cancer Center USC 2 Recruiting
Los Angeles, California, United States, 90033
Contact: Shirley Sian    323-865-0452    shirley.sian@med.usc.edu   
Principal Investigator: Agustin Garcia         
Cedars Sinai Medical Center TKI258A2211 (SC) Recruiting
Los Angeles, California, United States, 90048
Contact: Rose Estrada    310-423-6595    Rose.Estrada@cshs.org   
Principal Investigator: Bobbie Jo Y. Rimel         
University of California at Los Angeles TORI Central Monitring Site Withdrawn
Los Angeles, California, United States, 90095
Central Coast Medical Oncology Corporation Recruiting
Santa Maria, California, United States, 93454
Contact    805-739-3724      
Principal Investigator: Robert Dichmann         
United States, Colorado
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer Recruiting
Greenwood Village, Colorado, United States
Contact: Mary Rigden    303-285-5081    mary.rigden@usoncology.com   
Principal Investigator: Ling Ma         
United States, Connecticut
Yale University School of Medicine Yale SC Recruiting
New Haven, Connecticut, United States, 06520
Contact: Michele Montagna    203-785-6398    michele.montagna@yale.edu   
Principal Investigator: Alessandro Santin         
United States, Florida
Florida Hospital Cancer Institute FL Hosp Recruiting
Orlando, Florida, United States, 32806
Contact: Deborah Sams    407-303-2091    Deborah.Sams@FLHOSP.ORG   
Principal Investigator: Neil Finkler         
Memorial Cancer Institute Memorial Cancer Withdrawn
Pembroke Pines, Florida, United States, 33028
United States, Hawaii
Queen's Medical Center Queen Withdrawn
Honolulu, Hawaii, United States, 96817
United States, Illinois
Northwestern University Northwestern Withdrawn
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Health Goshen Center for Cancer IU Simon Cancer Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Carol Kulesavage    317-274-0757    ckulesav@iupui.edu   
Principal Investigator: Daniela Matei         
United States, Iowa
University of Iowa Hospitals & Clinics SC Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jessica Janecek    319-356-2015    jessica-janecek@uiowa.edu   
Principal Investigator: David Bender         
United States, Kansas
University of Kansas Cancer Center Univ KS Withdrawn
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Dana Farber Cancer Institute SC Recruiting
Boston, Massachusetts, United States, 02115
Contact: Llazar M Cuko    617-632-2166    lcuko@partners.org   
Principal Investigator: Neil Horowitz         
Massachusetts General Hospital Univ of Mass. Medical Ctr. Withdrawn
Boston, Massachusetts, United States, 02114
United States, Nebraska
Southeast Nebraska Oncology Cancer Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Sarah Mayo    402-327-7363    sarahm@leadingcancercare.com   
Principal Investigator: Steven Dunder         
United States, New Jersey
Morristown Memorial Hospital SC Recruiting
Morristown, New Jersey, United States, 07962
Contact: Nelli Savkina    973-971-5235    nelli.savkina@atlantichealth.org   
Principal Investigator: Brian M. Slomovitz         
United States, North Carolina
Hope A Woman's Cancer Center Recruiting
Asheville, North Carolina, United States, 28806
Contact: Ruth Gonzalez    828-670-8403    RNGonzalez@mednet.ucla.edu   
Principal Investigator: Timothy J Vanderkwaak         
Duke University Medical Center Duke3 Recruiting
Durham, North Carolina, United States, 27710
Contact: Elizabeth Bennett    919-681-9777    elizabeth.bennett2@dm.duke.edu   
Principal Investigator: Paula Lee         
United States, South Carolina
Cancer Centers of the Carolinas SC-1 Recruiting
Greenville, South Carolina, United States, 29605
Contact: Alexis Kelly       alexis.kelly@usoncology.com   
Principal Investigator: David Jeffery Griffin         
United States, Tennessee
Community Oncology Research Network Terminated
Chattanooga, Tennessee, United States, 37403
The West Clinic SC Recruiting
Memphis, Tennessee, United States, 38120
Contact: Mariesha Williams    901-683-0055    mawilliams@westclinic.com   
Principal Investigator: Todd Tillmanns         
Vanderbilt University Medical Center SC-2 Recruiting
Nashville, Tennessee, United States, 37232
Contact: Katie C. Lyons    615-936-5786    katie.lyons@Vanderbilt.Edu   
Principal Investigator: Marta A. Crispens         
United States, Texas
Texas Oncology, P.A. Austin Recruiting
Bedford, Texas, United States, 76022
Contact: Liela Terada    512-421-4163    leila.terada@usoncology.com   
Principal Investigator: Michael Teneriello         
Texas Oncology, P.A. Tex Onc (3) Recruiting
Bedford, Texas, United States, 76022
Contact: Autumn Potter    817-359-9033    autumn.potter@usoncology.com   
Principal Investigator: Mark Messing         
US Oncology Central Monitoring Withdrawn
Dallas, Texas, United States, 75246
Texas Oncology, P.A. SC Recruiting
Fort Worth, Texas, United States, 76104
Contact: Karen Haas       karen.haas@usoncology.com   
Principal Investigator: Noelle Cloven         
South Texas Oncology and Hematology, PA South Tex Onc Recruiting
San Antonio, Texas, United States, 78258
Contact: Crystal Castillo    210-593-2572    crystal.castillo@start.stoh.com   
Principal Investigator: Allan White         
United States, Utah
University of Utah / Huntsman Cancer Institute HCI Withdrawn
Salt Lake City, Utah, United States, 84103
United States, Virginia
Virginia Oncology Associates VOA - Lake Wright Recruiting
*see Various Departments*, Virginia, United States
Contact: Alison Payne    757-213-5637    alison.payne@usoncology.com   
Principal Investigator: Michael McCollum         
United States, Washington
Cancer Care Northwest SC Recruiting
Spokane, Washington, United States, 99202
Contact: Audrey Grayhek    509-228-1083    audrey.grayhek@ccnw.net   
Principal Investigator: Melanie Bergman         
Brazil
Novartis Investigative Site Recruiting
Belo Horizonte, MG, Brazil, 30150-270
Novartis Investigative Site Recruiting
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site Recruiting
Ribeirao Preto, SP, Brazil, 14048-900
Egypt
Novartis Investigative Site Withdrawn
Cairo, Egypt
Italy
Novartis Investigative Site Recruiting
Genova, GE, Italy, 16132
Novartis Investigative Site Recruiting
Monza, MB, Italy, 20900
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Recruiting
Pisa, PI, Italy, 56126
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00168
Novartis Investigative Site Recruiting
Candiolo, TO, Italy, 10060
Korea, Republic of
Novartis Investigative Site Withdrawn
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site Terminated
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site Terminated
Seoul, Korea, Republic of, 738-736
New Zealand
Novartis Investigative Site Recruiting
Grafton, Auckland, New Zealand
Spain
Novartis Investigative Site Recruiting
Cordoba, Andalucia, Spain, 14004
Novartis Investigative Site Recruiting
Málaga, Andalucia, Spain, 29010
Novartis Investigative Site Recruiting
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site Recruiting
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site Recruiting
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site Recruiting
Majadanonda, Madrid, Spain, 28220
Novartis Investigative Site Recruiting
Murcia, Spain, 30008
United Kingdom
Novartis Investigative Site Recruiting
Glasgow, United Kingdom, G12 0YN
Novartis Investigative Site Recruiting
Leeds, United Kingdom, LS9 7TF
Novartis Investigative Site Recruiting
London, United Kingdom, NW1 2BU
Novartis Investigative Site Recruiting
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01379534     History of Changes
Other Study ID Numbers: CTKI258A2211, 2011-000266-35
Study First Received: June 6, 2011
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institutes for Drugs and Medical Devices (BfArM)
Netherlands: Medicines Evaluation Board
Singapore: Health Science Authority
Italy: Italian Medicines Agency (AIFA)

Keywords provided by Novartis:
Solid tumors,
advanced endometrial cancer,
Endometrial Cancer,
Second-line treatment,
VEGF,
Neoplasms,
Endometrial Neoplasms,
Uterine Neoplasms,
Female Genital Neoplasms,
Cancer,
Carcinoma,
Uterine Diseases,
Female Genital Diseases,
Tumors,
Oral Administration,
Capsules,
Tablets,
CHIR258,
CHIR-258,
CHIR 258,
TKI258,
TKI-258,
TKI 258

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on April 17, 2014