Back to resultsStudy of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
Primary Purpose
Endometrial Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BN83495
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
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.
Sites / Locations
- Dept of Obstetrics and Gynecology, Medical College of Georgia
- Division of Gynecologic Oncology, University of Minnesota Medical Center
- Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
- Crozer Chester medical Center
- London Health Sciences Centre, University of Western Ontario
- Department of Oncology, Ottawa Cancer Center
- Dept of Obstetrics and Gynecology, Princess Margaret Hospital
- CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
- Department of Oncology, McGill University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BN83495
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of Participants With Adverse Events
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.
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.
Determination of Overall Response Rate (ORR) in This Patient Population
Overall Response Rate (ORR): Defined as the sum of CR and PR.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01251354
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BN83495
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BN83495
Intervention Description
1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Primary Outcome Measure Information:
Title
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)
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
Up to 28 days after last dose
Title
Determination of Time to Progression (TTP) in This Patient Population
Description
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
Title
Determination of Progression Free Survival (PFS) in This Patient Population
Description
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
Title
Determination of Overall Response Rate (ORR) in This Patient Population
Description
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
Title
Determination of Duration of Response in This Patient Population
Description
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
Title
Determination of Overall Survival in This Patient Population
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Dept of Obstetrics and Gynecology, Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Division of Gynecologic Oncology, University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Crozer Chester medical Center
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
London Health Sciences Centre, University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Department of Oncology, Ottawa Cancer Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Dept of Obstetrics and Gynecology, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Department of Oncology, McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
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