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

Endometrial Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01251354
• Other study ID #: X-52-58064-007
• Status: Terminated
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• BN83495
1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University of Western Ontario	London	Ontario
Canada	CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique	Montreal	Quebec
Canada	Department of Oncology, McGill University	Montreal	Quebec
Canada	Department of Oncology, Ottawa Cancer Center	Ottawa	Ontario
Canada	Dept of Obstetrics and Gynecology, Princess Margaret Hospital	Toronto	Ontario
United States	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	Crozer Chester medical Center	Upland	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	12 weeks
Secondary	Number of Participants With Adverse Events		Up to 28 days after last dose
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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