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

Ipsen

Status and phase: Terminated; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: BN83495

Study type: Interventional

Funder types: Industry

Identifiers

NCT01251354

X-52-58064-007

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

BN83495

Experimental group

Treatment:

Drug: BN83495