Trial Outcomes & Findings for The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer (NCT NCT00910091)
NCT ID: NCT00910091
Last Updated: 2019-01-30
Results Overview
Subject continuation in the study and Response Evaluation Criteria in Solid Tumours (RECIST) assessment has been based on investigator assessment and not on central review. The 6 month timepoint is defined as the treatment start date +183 days (26 weeks).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2019-01-30
Participant Flow
Participant milestones
| Measure |
Arm A: BN83495 40 mg
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
Megestrol Acetate (MA) 160 mg tablet by mouth once daily
|
|---|---|---|
|
Pre-assignment
STARTED
|
36
|
37
|
|
Pre-assignment
COMPLETED
|
36
|
35
|
|
Pre-assignment
NOT COMPLETED
|
0
|
2
|
|
Treatment and Survival
STARTED
|
36
|
35
|
|
Treatment and Survival
COMPLETED
|
32
|
31
|
|
Treatment and Survival
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Arm A: BN83495 40 mg
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
Megestrol Acetate (MA) 160 mg tablet by mouth once daily
|
|---|---|---|
|
Pre-assignment
Withdrawal by Subject
|
0
|
2
|
|
Treatment and Survival
Withdrawal by Subject
|
3
|
4
|
|
Treatment and Survival
Adverse Event
|
1
|
0
|
Baseline Characteristics
The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=37 Participants
MA 160 mg tablet by mouth once daily
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
67.4 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
67.7 Years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Age, Customized
18-64 years
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Customized
65-75 years
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Customized
>75 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Moldova, Republic of
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI (Body Mass Index)
<18.5 kg/m2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI (Body Mass Index)
18.5 - 25 kg/m2
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
BMI (Body Mass Index)
>25 - 30 kg/m2
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
BMI (Body Mass Index)
>30 kg/m2
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
BMI (Body Mass Index)
Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race
Black / African American
|
0 Subjects
n=5 Participants
|
1 Subjects
n=7 Participants
|
1 Subjects
n=5 Participants
|
|
Race
Caucasian / White
|
36 Subjects
n=5 Participants
|
36 Subjects
n=7 Participants
|
72 Subjects
n=5 Participants
|
|
Eastern Cooperative Oncology Group(ECOG) Performance Status Score
|
0.8 Units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.7 Units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
0.7 Units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Intent-to-treat (ITT) population includes all randomized subjects who received at least one dose of study medication.
Subject continuation in the study and Response Evaluation Criteria in Solid Tumours (RECIST) assessment has been based on investigator assessment and not on central review. The 6 month timepoint is defined as the treatment start date +183 days (26 weeks).
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=37 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died
|
36.1 Percentage of subjects
Interval 24.3 to 49.8
|
54.1 Percentage of subjects
Interval 40.8 to 66.8
|
SECONDARY outcome
Timeframe: Up to Day 28 follow-upPopulation: Safety Population: All randomised subjects who received at least one dose of study medication.
Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening/disabling and Grade 5: Death
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=35 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Percentage of Participants With Adverse Event (AE)
Any AEs
|
88.9 Percentage of subjects
|
82.9 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Any Treatment Emergent AEs (TEAEs)
|
88.9 Percentage of subjects
|
82.9 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Intensity of TEAEs - Grade 5
|
2.8 Percentage of subjects
|
2.9 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Intensity of TEAEs - Grade 4
|
5.6 Percentage of subjects
|
0.0 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Intensity of TEAEs - Grade 3
|
22.2 Percentage of subjects
|
25.7 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Intensity of TEAEs - Grade 2
|
63.9 Percentage of subjects
|
45.7 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Intensity of TEAEs - Grade 1
|
80.6 Percentage of subjects
|
74.3 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Intensity of TEAEs - Missing
|
5.6 Percentage of subjects
|
0.0 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Causality of TEAEs - Related
|
55.6 Percentage of subjects
|
37.1 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Causality of TEAEs - Not related
|
77.8 Percentage of subjects
|
77.1 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
TEAEs Leading to Withdrawal
|
8.3 Percentage of subjects
|
2.9 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
TEAEs Leading to Death
|
2.8 Percentage of subjects
|
2.9 Percentage of subjects
|
|
Percentage of Participants With Adverse Event (AE)
Serious Adverse Events (SAEs)
|
25.0 Percentage of subjects
|
17.1 Percentage of subjects
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Safety Population
Length of exposure includes interruptions.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=35 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Tolerability of BN83495 Based on Length of Exposure
|
34.94 Week
Standard Deviation 38.85
|
55.20 Week
Standard Deviation 49.48
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Safety Population Missing number of subjects = 2
Cumulative dose is the actual total dose administered.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=33 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Tolerability of BN83495 Based on Cumulative Dose Administered
|
9452.22 mg
Standard Deviation 10799.16
|
60703.03 mg
Standard Deviation 51726.14
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Safety Population
Percentage of participants who had dose interruptions and reason for interruptions as AE, study treatment forgotten, and other reasons.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=35 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions
Reason for Interruptions (Treatment forgotten)
|
0.0 Percentage of participants
|
8.6 Percentage of participants
|
|
Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions
Dose Interruptions
|
27.8 Percentage of participants
|
34.5 Percentage of participants
|
|
Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions
Reason for Interruptions (AE)
|
16.7 Percentage of participants
|
8.6 Percentage of participants
|
|
Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions
Reason for Interruptions (Other)
|
13.9 Percentage of participants
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to week 32Population: ITT population. Three subjects withdrawn the consent from MA 160 mg group and did not have EuroQoL score up to week 32.
EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) is a participant answered questionnaire scoring 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=24 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=18 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
No Change or Deterioration at week 8
|
25.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
No Change or Deterioration at week 16
|
25.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
No Change or Deterioration at week 24
|
16.7 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
No Change or Deterioration at week 32
|
16.7 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of <10% at week 2
|
0.0 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of <10% at week 4
|
4.2 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of <10% at week 8
|
4.2 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of <10% at week 16
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of <10% at week 24
|
0.0 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of <10% at week 32
|
8.3 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of ≥10% at week 2
|
20.8 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of ≥10% at week 4
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of ≥10% at week 8
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of ≥10% at week 16
|
12.5 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
No Change or Deterioration at week 2
|
54.2 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
No Change or Deterioration at week 4
|
54.2 Percentage of participants
|
61.1 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of ≥10% at week 24
|
12.5 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score
Improvement of ≥10% at week 32
|
0.0 Percentage of participants
|
5.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: ITT population.
CR: Disappearance of all known disease \& no new sites / disease related symptoms confirmed at least 12 weeks after initial documentation. Disappearance of all non-target lesions. Normalization of tumor marker level confirmed at least 12 weeks after initial documentation. PR: Minimum 30% decrease in sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 12 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=37 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit [Including Completed Response (CR), Partial Response (PR), and Stable Disease (SD)] ≥12 Weeks
|
13 Percentage of Participants
Standard Deviation 36.1
|
19 Percentage of Participants
Standard Deviation 51.4
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: ITT population.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=37 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Percentage of Participants With Overall Response (OR) Including CR and PR
|
3 Percentage of Participants
Standard Deviation 8.3
|
11 Percentage of Participants
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: ITT population.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=37 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Percentage of Participants With First Documentation of Objective Tumour Progression From Randomisation
|
30 Percentage of Participants
Standard Deviation 83.3
|
24 Percentage of Participants
Standard Deviation 64.9
|
SECONDARY outcome
Timeframe: At 2 yearsPopulation: ITT population.
DR is defined as period from the time that measurement criteria are first met for CR or PR until first date of documented Progressive Disease (PD) or death. DR was assessed in participants with a best overall response of CR or PR.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=37 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Duration of Response (DR) in Responders
|
NA Weeks
Interval 23.14 to
NA = Values are not calculable
|
105.14 Weeks
Interval 47.71 to
NA = Values are not calculable
|
SECONDARY outcome
Timeframe: At 2 yearsPopulation: ITT population.
OS is defined as the time from the date of enrollment to the date of death due to any cause.
Outcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=37 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Overall Survival (OS)
|
63.43 Weeks
Interval 37.57 to 100.29
|
NA Weeks
Interval 56.14 to
NA = Values are not calculable
|
SECONDARY outcome
Timeframe: Up to 2 yearsOutcome measures
| Measure |
Arm A: BN83495 40 mg
n=36 Participants
BN83495 (Irosustat) 40 mg tablet by mouth once daily
|
Arm B: MA 160 mg
n=37 Participants
MA 160 mg tablet by mouth once daily
|
|---|---|---|
|
Progression Free Survival (PFS): Time From Randomisation Until Objective Tumour Progression or Death From Any Cause
|
16.14 Weeks
Interval 9.0 to 31.43
|
40.14 Weeks
Interval 16.29 to 64.0
|
Adverse Events
A- BN 83495- 40mg
Serious events: 9 serious events
Other events: 32 other events
Deaths: 0 deaths
B- MA - 160mg
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A- BN 83495- 40mg
n=36 participants at risk
After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service
BN83495: BN83495 will be administered as a 40 mg tablet once a day orally
|
B- MA - 160mg
n=35 participants at risk
After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service
Megestrol Acetate (MA): MA will be administered orally as 160mg daily
|
|---|---|---|
|
Renal and urinary disorders
Haematuria
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/36 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
General disorders
Asthenia
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
2.8%
1/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/36 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/36 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/36 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
Other adverse events
| Measure |
A- BN 83495- 40mg
n=36 participants at risk
After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service
BN83495: BN83495 will be administered as a 40 mg tablet once a day orally
|
B- MA - 160mg
n=35 participants at risk
After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service
Megestrol Acetate (MA): MA will be administered orally as 160mg daily
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
19.4%
7/36 • Number of events 7 • Up to Day 28 follow-up
|
8.6%
3/35 • Number of events 3 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • Number of events 6 • Up to Day 28 follow-up
|
11.4%
4/35 • Number of events 4 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Constipation
|
13.9%
5/36 • Number of events 5 • Up to Day 28 follow-up
|
11.4%
4/35 • Number of events 4 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
13.9%
5/36 • Number of events 5 • Up to Day 28 follow-up
|
17.1%
6/35 • Number of events 6 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Dry Mouth
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
8.6%
3/35 • Number of events 3 • Up to Day 28 follow-up
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
38.9%
14/36 • Number of events 14 • Up to Day 28 follow-up
|
14.3%
5/35 • Number of events 5 • Up to Day 28 follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
General disorders
Asthenia
|
16.7%
6/36 • Number of events 6 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
General disorders
Fatigue
|
16.7%
6/36 • Number of events 6 • Up to Day 28 follow-up
|
11.4%
4/35 • Number of events 4 • Up to Day 28 follow-up
|
|
General disorders
Spinal Pain
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
General disorders
Oedema Peripheral
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.3%
3/36 • Number of events 3 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
3/36 • Number of events 3 • Up to Day 28 follow-up
|
14.3%
5/35 • Number of events 5 • Up to Day 28 follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Infections and infestations
Cystitis
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Infections and infestations
Urinary Tract Infection
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
17.1%
6/35 • Number of events 6 • Up to Day 28 follow-up
|
|
Renal and urinary disorders
Dysuria
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
4/36 • Number of events 4 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Investigations
Blood Creatinine Increased
|
8.3%
3/36 • Number of events 3 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Investigations
Blood Urea Increased
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Nervous system disorders
Headache
|
8.3%
3/36 • Number of events 3 • Up to Day 28 follow-up
|
2.9%
1/35 • Number of events 1 • Up to Day 28 follow-up
|
|
Nervous system disorders
Dysgeusia
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Nervous system disorders
Lethargy
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Vascular disorders
Hypertension
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
11.4%
4/35 • Number of events 4 • Up to Day 28 follow-up
|
|
Vascular disorders
Hot Flush
|
0.00%
0/36 • Up to Day 28 follow-up
|
8.6%
3/35 • Number of events 3 • Up to Day 28 follow-up
|
|
Psychiatric disorders
Depression
|
2.8%
1/36 • Number of events 1 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
5.6%
2/36 • Number of events 2 • Up to Day 28 follow-up
|
0.00%
0/35 • Up to Day 28 follow-up
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
|
Immune system disorders
Contrast Media Allergy
|
0.00%
0/36 • Up to Day 28 follow-up
|
5.7%
2/35 • Number of events 2 • Up to Day 28 follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place