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

Completed · Phase 2

Conditions studied: Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer, Second-line Treatment, VEGF

In brief

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.

Key facts

Study ID

NCT01379534

Run by

Novartis Pharmaceuticals

People needed

53

Starts

2011-11-01

Expected to finish

2014-03-01

Last updated by the study team

2015-05-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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