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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: BN83495


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BN83495<br> | Drug: BN83495<br>* 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | 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. | 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. | 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 | Overall Response Rate (ORR): Defined as the sum of CR and PR. | 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. | 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. | 2 years after the last patient enrolled |