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.

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 Overview

• Status: Terminated
• Conditions: Endometrial Cancer
• Intervention / Treatment: Drug: BN83495

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • London Health Sciences Centre, University of Western Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Department of Oncology, Ottawa Cancer Center
    • Toronto, Ontario, Canada, M5G 2M9
      • Dept of Obstetrics and Gynecology, Princess Margaret Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
    • Montreal, Quebec, Canada, H2W 1S6
      • Department of Oncology, McGill University
• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Dept of Obstetrics and Gynecology, Medical College of Georgia
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Division of Gynecologic Oncology, University of Minnesota Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
    • Upland, Pennsylvania, United States, 19103
      • Crozer Chester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BN83495	Drug: BN83495; 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 1, 2010

Study Record Updates

• Last Update Posted (Actual): January 14, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: X-52-58064-007