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
Description
Brief 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.
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
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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
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Washington
- Cancer Care Northwest SC, Spokane, Washington, 99202
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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
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Nebraska
- Southeast Nebraska Oncology Cancer Center, Lincoln, Nebraska, 68510
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Iowa
- University of Iowa Hospitals & Clinics SC, Iowa City, Iowa, 52242
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Tennessee
- The West Clinic SC, Memphis, Tennessee, 38120
- Community Oncology Research Network, Chattanooga, Tennessee, 37403
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Alabama
- University of South Alabama / Mitchell Cancer Institute Univ South Alabama, Mobile, Alabama, 36688
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Indiana
- Indiana University Health Goshen Center for Cancer IU Simon Cancer, Indianapolis, Indiana, 46202
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PI
- Novartis Investigative Site, Pisa, PI, 56126
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Spain
- Novartis Investigative Site, Murcia, 30008
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