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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Dept of Obstetrics and Gynecology, Medical College of Georgia
Augusta, Georgia, United States
Division of Gynecologic Oncology, University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
Philadelphia, Pennsylvania, United States
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)
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).
Time frame: 12 weeks
Number of Participants With Adverse Events
Time frame: Up to 28 days after last dose
Determination of Time to Progression (TTP) in This Patient Population
Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.
Time frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Progression Free Survival (PFS) in This Patient Population
Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.
Time frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Overall Response Rate (ORR) in This Patient Population
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Crozer Chester medical Center
Upland, Pennsylvania, United States
London Health Sciences Centre, University of Western Ontario
London, Ontario, Canada
Department of Oncology, Ottawa Cancer Center
Ottawa, Ontario, Canada
Dept of Obstetrics and Gynecology, Princess Margaret Hospital
Toronto, Ontario, Canada
CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
Montreal, Quebec, Canada
Department of Oncology, McGill University
Montreal, Quebec, Canada
Overall Response Rate (ORR): Defined as the sum of CR and PR.
Time frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Duration of Response in This Patient Population
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.
Time frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died
Determination of Overall Survival in This Patient Population
Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.
Time frame: 2 years after the last patient enrolled