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

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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01251354

Enrollment

Registered

2010-12-01

Start date

2010-11-30

Completion date

2011-07-31

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

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.

Interventions

DRUGBN83495

1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
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.
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.

Countries

Canada, United States

Participant flow

Recruitment details

Participants were recruited from United States of America and Canada from 08-Feb-2011. Terminated on 06-Jun-2011 and Study Completion was on 26-Jul-2011.

Pre-assignment details

Six patients from five centres were screened for inclusion. All six patients were enrolled and treated

Participants by arm

Arm	Count
BN83495 BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops	6
Total	6

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Disease Progression	4
Overall Study	Investigator's Decision	1

Baseline characteristics

Characteristic	BN83495
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	2 Participants
Age, Categorical Between 18 and 65 years	4 Participants
Race/Ethnicity, Customized Asian	1 participants
Race/Ethnicity, Customized Black / African American	1 participants
Race/Ethnicity, Customized Caucasian / White	3 participants
Race/Ethnicity, Customized Unknown	1 participants
Region of Enrollment Canada	4 participants
Region of Enrollment United States	2 participants
Sex/Gender, Customized Female	6 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	6 / 6
serious Total, serious adverse events	2 / 6

Outcome results

Primary

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