Clinical trial NCT01251354: Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometrial Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
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)
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 28 days after last dose
measure: Determination of Time to Progression (TTP) in This Patient Population
timeFrame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
measure: Determination of Progression Free Survival (PFS) in This Patient Population
timeFrame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
measure: Determination of Overall Response Rate (ORR) in This Patient Population
timeFrame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
measure: Determination of Duration of Response in This Patient Population
timeFrame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
measure: Determination of Overall Survival in This Patient Population
timeFrame: 2 years after the last patient enrolled
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Dept of Obstetrics and Gynecology, Medical College of Georgia
state: Georgia
city: Minneapolis
country: United States
facility: Division of Gynecologic Oncology, University of Minnesota Medical Center
state: Minnesota
city: Philadelphia
country: United States
facility: Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
state: Pennsylvania
city: Upland
country: United States
facility: Crozer Chester medical Center
state: Pennsylvania
city: London
country: Canada
facility: London Health Sciences Centre, University of Western Ontario
state: Ontario
city: Ottawa
country: Canada
facility: Department of Oncology, Ottawa Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Dept of Obstetrics and Gynecology, Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
state: Quebec
city: Montreal
country: Canada
facility: Department of Oncology, McGill University
state: Quebec
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: