Status:
TERMINATED
Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
Lead Sponsor:
Ipsen
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
Eligibility Criteria
Inclusion
- Provision of written informed consent prior to any study related procedures.
- postmenopausal or ovariectomised female patient over 18 years of age.
- histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
- patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
- patient has at least one measurable disease site (RECIST criteria version 1.1)
Exclusion
- patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
- patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
- patient was treated with any other investigational agent within the 3 weeks before study entry.
- patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval \>460 msec.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01251354
Start Date
November 1 2010
End Date
July 1 2011
Last Update
January 14 2019
Active Locations (9)
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1
Dept of Obstetrics and Gynecology, Medical College of Georgia
Augusta, Georgia, United States, 30912
2
Division of Gynecologic Oncology, University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
3
Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
4
Crozer Chester medical Center
Upland, Pennsylvania, United States, 19103