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
NCT ID: NCT01379534
Last Updated: 2015-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2011-11-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TKI258
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
TKI258
Interventions
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TKI258
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama / Mitchell Cancer Institute Univ South Alabama
Mobile, Alabama, United States
St. Jude Heritage Medical Group St Jude
Fullerton, California, United States
USC/Kenneth Norris Comprehensive Cancer Center USC 2
Los Angeles, California, United States
Cedars Sinai Medical Center TKI258A2211 (SC)
Los Angeles, California, United States
University of California at Los Angeles UCLA 3
Los Angeles, California, United States
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
Greenwood Village, Colorado, United States
Florida Hospital Cancer Institute FL Hosp
Orlando, Florida, United States
Indiana University Health Goshen Center for Cancer IU Simon Cancer
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics SC
Iowa City, Iowa, United States
Dana Farber Cancer Institute SC
Boston, Massachusetts, United States
Southeast Nebraska Oncology Cancer Center
Lincoln, Nebraska, United States
Hope A Woman's Cancer Center
Asheville, North Carolina, United States
Duke University Medical Center Duke3
Durham, North Carolina, United States
Community Oncology Research Network
Chattanooga, Tennessee, United States
The West Clinic SC
Memphis, Tennessee, United States
Texas Oncology, P.A. Austin
Bedford, Texas, United States
Texas Oncology, P.A. Tex Onc (3)
Bedford, Texas, United States
Texas Oncology, P.A. SC
Fort Worth, Texas, United States
South Texas Oncology and Hematology, PA South Tex Onc
San Antonio, Texas, United States
Virginia Oncology Associates VOA - Lake Wright
*see Various Departments*, Virginia, United States
Cancer Care Northwest SC
Spokane, Washington, United States
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Ribeirão Preto, São Paulo, Brazil
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Monza, MB, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Candiolo, TO, Italy
Novartis Investigative Site
Grafton, Auckland, , New Zealand
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Córdoba, Andalusia, Spain
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Sabadell, Barcelona, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Majadahonda, Madrid, Spain
Novartis Investigative Site
Murcia, Murcia, Spain
Novartis Investigative Site
Oviedo, Principality of Asturias, Spain
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
Leeds, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Nottingham, , United Kingdom
Countries
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References
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Konecny GE, Finkler N, Garcia AA, Lorusso D, Lee PS, Rocconi RP, Fong PC, Squires M, Mishra K, Upalawanna A, Wang Y, Kristeleit R. Second-line dovitinib (TKI258) in patients with FGFR2-mutated or FGFR2-non-mutated advanced or metastatic endometrial cancer: a non-randomised, open-label, two-group, two-stage, phase 2 study. Lancet Oncol. 2015 Jun;16(6):686-94. doi: 10.1016/S1470-2045(15)70159-2. Epub 2015 May 13.
Other Identifiers
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2011-000266-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTKI258A2211
Identifier Type: -
Identifier Source: org_study_id
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