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



Status:Terminated
Conditions:Cervical Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:November 2010
End Date:July 2011

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A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.

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.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
5
sites
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Philadelphia, PA
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Augusta, GA
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1153 Western Road
London, Ontario N6G 1G6
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from
London,
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from
Minneapolis, MN
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Upland, Pennsylvania 19013
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mi
from
Upland, PA
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