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

Phase 2

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
BN83495	BN83495	-

Primary Outcome Measures

Name	Time	Method
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)	12 weeks	CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study. PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Secondary Outcome Measures

Name	Time	Method
Determination of Overall Survival in This Patient Population	2 years after the last patient enrolled	Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.
Number of Participants With Adverse Events	Up to 28 days after last dose
Determination of Time to Progression (TTP) in This Patient Population	After the last enrolled patient has been followed for at least 6 months or has progressed or died	Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.
Determination of Progression Free Survival (PFS) in This Patient Population	After the last enrolled patient has been followed for at least 6 months or has progressed or died	Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.
Determination of Overall Response Rate (ORR) in This Patient Population	After the last enrolled patient has been followed for at least 6 months or has progressed or died	Overall Response Rate (ORR): Defined as the sum of CR and PR.
Determination of Duration of Response in This Patient Population	After the last enrolled patient has been followed for at least 6 months or has progressed or died	Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.

Locations (9): Dept of Obstetrics and Gynecology, Medical College of Georgia
🇺🇸
Augusta, Georgia, United States
Dept of Obstetrics and Gynecology, Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada
London Health Sciences Centre, University of Western Ontario
🇨🇦
London, Ontario, Canada
Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Department of Oncology, Ottawa Cancer Center
🇨🇦
Ottawa, Ontario, Canada
CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
🇨🇦
Montreal, Quebec, Canada
Division of Gynecologic Oncology, University of Minnesota Medical Center
🇺🇸
Minneapolis, Minnesota, United States
Crozer Chester medical Center
🇺🇸
Upland, Pennsylvania, United States
Department of Oncology, McGill University
🇨🇦
Montreal, Quebec, Canada