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5U-11-1-A Phase II, Open-Label, Single-Arm, Non-Randomized, Multicenter 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

Description

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.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion 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

  • 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

Sites

  • California

    • USC/Kenneth Norris Comprehensive Cancer Center USC 2, Los Angeles, California, 90033
    • Cedars Sinai Medical Center TKI258A2211 (SC), Los Angeles, California, 90048
    • University of California at Los Angeles UCLA 3, Los Angeles, California, 90095
    • St. Jude Heritage Medical Group St Jude, Fullerton, California, 92835
  • Washington

    • Cancer Care Northwest SC, Spokane, Washington, 99202
  • Texas

    • South Texas Oncology and Hematology, PA South Tex Onc, San Antonio, Texas, 78258
    • Texas Oncology, P.A. SC, Fort Worth, Texas, 76104
    • Texas Oncology, P.A. Austin, Bedford, Texas, 76022
    • Texas Oncology, P.A. Tex Onc (3), Bedford, Texas, 76022
  • Nebraska

    • Southeast Nebraska Oncology Cancer Center, Lincoln, Nebraska, 68510
  • Iowa

    • University of Iowa Hospitals & Clinics SC, Iowa City, Iowa, 52242
  • Tennessee

    • The West Clinic SC, Memphis, Tennessee, 38120
    • Community Oncology Research Network, Chattanooga, Tennessee, 37403
  • Alabama

    • University of South Alabama / Mitchell Cancer Institute Univ South Alabama, Mobile, Alabama, 36688
  • Indiana

    • Indiana University Health Goshen Center for Cancer IU Simon Cancer, Indianapolis, Indiana, 46202
  • PI

    • Novartis Investigative Site, Pisa, PI, 56126
  • Spain

    • Novartis Investigative Site, Murcia, 30008
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