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



Status:Recruiting
Conditions:Cervical Cancer, Cancer, Endometrial Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:November 2011
End Date:July 2016
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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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

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.


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
We found this trial at
34
sites
Chicago, Illinois 60611
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220 S Palisade Dr # 204
Santa Maria, California 93454
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Santa Maria, CA
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*see Various Departments*, Virginia
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Asheville, North Carolina 28816
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Bedford, Texas 76022
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Bedford, Texas 76022
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Bedford, TX
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Boston, Massachusetts 02115
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Boston, MA
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Chattanooga, Tennessee 37403
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Dallas, Texas 75246
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Durham, North Carolina 27710
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Durham, NC
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Fort Worth, Texas 76104
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Fullerton, California 92835
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Fullerton, CA
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Greenville, South Carolina 29605
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Greenwood Village, CO
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Honolulu, Hawaii 96817
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Indianapolis, IN
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Iowa City, IA
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Kansas City, KS
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Lincoln, NE
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Los Angeles, California 90095
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Los Angeles, California 90048
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Memphis, Tennessee 38120
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Mobile, AL
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Morristown, New Jersey 07962
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Nashville, Tennessee 37232
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New Haven, Connecticut 06520
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Pembroke Pines, Florida 33028
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Salt Lake City, UT
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Spokane, Washington 99202
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Spokane, WA
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