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

This study has been terminated.
(The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.)
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT01251354
First received: November 23, 2010
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: BN83495
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Determination of time to progression (TTP) in this patient population [ Time Frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died ] [ Designated as safety issue: No ]
  • Determination of progression free survival (PFS) in this patient population [ Time Frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died ] [ Designated as safety issue: No ]
  • Determination of overall response (OR) in this patient population [ Time Frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died ] [ Designated as safety issue: No ]
  • Determination of duration of response in this patient population [ Time Frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died ] [ Designated as safety issue: No ]
  • Determination of overall survival in this patient population [ Time Frame: 2 years after the last patient enrolled ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BN83495 Drug: BN83495
1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251354

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

No publications provided

Responsible Party: Dr Anne Kornowski, Ipsen
ClinicalTrials.gov Identifier: NCT01251354     History of Changes
Other Study ID Numbers: X-52-58064-007
Study First Received: November 23, 2010
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

ClinicalTrials.gov processed this record on October 21, 2014