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

• Sponsor: Ipsen (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01251354
• Collaborator: (none)
• Enrollment: 6
• Locations: 9
• Arm: 1
• Duration (Months): 8
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: BN83495	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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) [12 weeks]

   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

1. Number of Participants With Adverse Events [Up to 28 days after last dose]

2. 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]

   Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.

3. 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]

   Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.

4. 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]

   Overall Response Rate (ORR): Defined as the sum of CR and PR.

5. 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]

   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.

6. Determination of Overall Survival in This Patient Population [2 years after the last patient enrolled]

   Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

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

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT01251354
• Other Study ID Numbers: X-52-58064-007
• First Posted: Dec 1, 2010
• Last Update Posted: Jan 14, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Endometrial Neoplasms

Study Results

Participant Flow

Recruitment Details	Participants were recruited from United States of America and Canada from 08-Feb-2011. Terminated on 06-Jun-2011 and Study Completion was on 26-Jul-2011.
Pre-assignment Detail	Six patients from five centres were screened for inclusion. All six patients were enrolled and treated

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Period Title: Overall Study
STARTED	6
COMPLETED	0
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 66.7%
>=65 years	2 33.3%
Sex/Gender, Customized (participants) [Number]
Female	6 100%
Race/Ethnicity, Customized (participants) [Number]
Caucasian / White	3 50%
Asian	1 16.7%
Black / African American	1 16.7%
Unknown	1 16.7%
Region of Enrollment (participants) [Number]
Canada	4 66.7%
United States	2 33.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Measure Participants	0

2. Secondary Outcome

Title	Number of Participants With Adverse Events
Time Frame	Up to 28 days after last dose

Outcome Measure Data

Analysis Population Description

All Screened Population

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Measure Participants	6
Number [participants]	6 100%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Measure Participants	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Measure Participants	0

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Measure Participants	0

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Measure Participants	0

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint

Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Measure Participants	0

Adverse Events

Time Frame	Up to 28 days after last dose
Adverse Event Reporting Description	Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
Arm/Group Title	BN83495
Arm/Group Description	BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
All Cause Mortality
	BN83495
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	BN83495
	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)
Gastrointestinal disorders
Colonic obstruction	1/6 (16.7%)	1
Injury, poisoning and procedural complications
Subdural hematoma	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	BN83495
	Affected / at Risk (%)	# Events
Total	6/6 (100%)
Gastrointestinal disorders
Nausea	3/6 (50%)
Vomiting	3/6 (50%)
Abdominal pain	2/6 (33.3%)
Constipation	2/6 (33.3%)
General disorders
Fatigue	2/6 (33.3%)
Metabolism and nutrition disorders
Decreased appetite	2/6 (33.3%)
Musculoskeletal and connective tissue disorders
Back pain	3/6 (50%)
Reproductive system and breast disorders
Vaginal discharge	3/6 (50%)

Limitations/Caveats

Study terminated due to poor enrollment

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.