Trial Outcomes & Findings for Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy (NCT NCT01251354)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-01-14

Participant Flow

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.

Six patients from five centres were screened for inclusion. All six patients were enrolled and treated

Participant milestones

Participant milestones
Measure	BN83495 BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	BN83495 BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Overall Study Adverse Event	1
Overall Study Investigator's Decision	1
Overall Study Disease Progression	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BN83495 n=6 Participants BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex/Gender, Customized Female	6 participants n=5 Participants
Race/Ethnicity, Customized Caucasian / White	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Black / African American	1 participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 days after last dose

Population: All Screened Population

Outcome measures

Outcome measures
Measure	BN83495 n=6 Participants BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Number of Participants With Adverse Events	6 participants

Adverse Events

BN83495

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BN83495 n=6 participants at risk BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Injury, poisoning and procedural complications Subdural hematoma	16.7% 1/6 • Number of events 1 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
Gastrointestinal disorders Colonic obstruction	16.7% 1/6 • Number of events 1 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.

Other adverse events

Other adverse events
Measure	BN83495 n=6 participants at risk BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Gastrointestinal disorders Nausea	50.0% 3/6 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
Gastrointestinal disorders Vomiting	50.0% 3/6 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
Gastrointestinal disorders Abdominal pain	33.3% 2/6 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
Gastrointestinal disorders Constipation	33.3% 2/6 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
Musculoskeletal and connective tissue disorders Back pain	50.0% 3/6 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
Reproductive system and breast disorders Vaginal discharge	50.0% 3/6 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
General disorders Fatigue	33.3% 2/6 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.
Metabolism and nutrition disorders Decreased appetite	33.3% 2/6 • Up to 28 days after last dose Treatment emergent Adverse Events (TEAEs) that were reported by more than one patient.

Additional Information

Medical Director, Oncology

Ipsen

Phone: [email protected]

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place