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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.


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of clinical benefit (CB), defined as sum of patients who present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 weeks (CB=CR+PR+SD≥12 weeks) using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Anne Kornowski, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

United States: Food and Drug Administration

Study ID:

X-52-58064-007

NCT ID:

NCT01251354

Start Date:

November 2010

Completion Date:

July 2011

Related Keywords:

  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Dept of Obstetrics and Gynecology, Medical College of Georgia Augusta, Georgia  30912
Division of Gynecologic Oncology, University of Minnesota Medical Center Minneapolis, Minnesota  55455
Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Crozer Chester medical Center Upland, Pennsylvania  19103