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

Use our guide to learn which trials are right for you!

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
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
220 S Palisade Dr # 204
Santa Maria, California 93454
?
mi
from
Santa Maria, CA
Click here to add this to my saved trials
*see Various Departments*, Virginia
?
mi
from
*see Various Departments*, VA
Click here to add this to my saved trials
Asheville, North Carolina 28816
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Bedford, Texas 76022
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Bedford, Texas 76022
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Dallas, Texas 75246
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Greenwood Village, CO
Click here to add this to my saved trials
Honolulu, Hawaii 96817
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Memphis, Tennessee 38120
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Morristown, New Jersey 07962
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut 06520
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Spokane, Washington 99202
?
mi
from
Spokane, WA
Click here to add this to my saved trials