Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy

Stopped early · Phase 2

Conditions studied: Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT01251354

Run by

Ipsen

People needed

6

Starts

2010-11-01

Expected to finish

2011-07-01

Last updated by the study team

2019-01-14

Who can join

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

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Dept of Obstetrics and Gynecology, Medical College of Georgia — Augusta, Georgia, United States
• Division of Gynecologic Oncology, University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Crozer Chester medical Center — Upland, Pennsylvania, United States
• London Health Sciences Centre, University of Western Ontario — London, Ontario, Canada
• Department of Oncology, Ottawa Cancer Center — Ottawa, Ontario, Canada
• Dept of Obstetrics and Gynecology, Princess Margaret Hospital — Toronto, Ontario, Canada
• CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique — Montreal, Quebec, Canada
• Department of Oncology, McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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