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

NCT01251354 | Terminated Phase 2 Results

• 1 other identifier: X-52-58064-007
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 9

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

Study Arms (1)

BN83495

EXPERIMENTAL

Drug: BN83495

Interventions

BN83495 DRUG

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

BN83495

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (9)

Dept of Obstetrics and Gynecology, Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Division of Gynecologic Oncology, University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Crozer Chester medical Center

Upland, Pennsylvania, 19103, United States

Location

London Health Sciences Centre, University of Western Ontario

London, Ontario, N6A 4L6, Canada

Location

Department of Oncology, Ottawa Cancer Center

Ottawa, Ontario, K1H 8L6, Canada

Location

Dept of Obstetrics and Gynecology, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique

Montreal, Quebec, H2L 4M1, Canada

Location

Department of Oncology, McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

irosustat

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

Study terminated due to poor enrollment

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: December 1, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 14, 2019
• Results First Posted: September 2, 2015

Record last verified: 2019-01

Locations

CA (5); US (4)