Trial Outcomes & Findings for Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma (NCT NCT02234115)
NCT ID: NCT02234115
Last Updated: 2019-03-05
Results Overview
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
137 participants
Primary outcome timeframe
baseline to 28 days, 28 days to 336 days
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Leuprolide Mesylate 50mg
All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
|
|---|---|
|
Overall Study
STARTED
|
137
|
|
Overall Study
ITT
|
137
|
|
Overall Study
PP
|
124
|
|
Overall Study
PK Subgroup
|
31
|
|
Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma
Baseline characteristics by cohort
| Measure |
Leuprolide Mesylate 50mg
n=137 Participants
All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
|
|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 28 days, 28 days to 336 daysPopulation: ITT
The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).
Outcome measures
| Measure |
Leuprolide Mesylate 50mg
n=137 Participants
All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
|
|---|---|
|
Efficacy of Leuprolide Mesylate (LMIS 50mg)
|
97.0 percentage of participants
Interval 92.2 to 98.9
|
SECONDARY outcome
Timeframe: 336 daysPopulation: Safety population
Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.
Outcome measures
| Measure |
Leuprolide Mesylate 50mg
n=137 Participants
All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
TEAE
|
114 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related AEs
|
85 Participants
|
|
Number of Participants With Adverse Events (AEs)
SAE
|
20 Participants
|
Adverse Events
Leuprolide Mesylate 50mg
Serious events: 20 serious events
Other events: 114 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Leuprolide Mesylate 50mg
n=137 participants at risk
All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.73%
1/137 • Number of events 2 • 336 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Cardiac disorders
Myocardial infarction
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Eye disorders
Vision blurred
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
General disorders
Asthenia
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
General disorders
Death
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
General disorders
Non-cardiac chest pain
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Infections and infestations
Bronchitis bacterial
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Infections and infestations
Clostridium difficile colitis
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Infections and infestations
Pneumonia
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.5%
2/137 • Number of events 2 • 336 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.73%
1/137 • Number of events 3 • 336 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Vascular disorders
Intermittent claudication
|
0.73%
1/137 • Number of events 1 • 336 days
|
|
Vascular disorders
Peripheral artery occlusion
|
0.73%
1/137 • Number of events 2 • 336 days
|
Other adverse events
| Measure |
Leuprolide Mesylate 50mg
n=137 participants at risk
All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336.
Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
|
|---|---|
|
General disorders
Fatigue
|
6.6%
9/137 • Number of events 10 • 336 days
|
|
General disorders
Injection site pain
|
7.3%
10/137 • Number of events 13 • 336 days
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
7/137 • Number of events 9 • 336 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
9/137 • Number of events 12 • 336 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
7/137 • Number of events 7 • 336 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
13/137 • Number of events 18 • 336 days
|
|
Renal and urinary disorders
Nocturia
|
5.8%
8/137 • Number of events 9 • 336 days
|
|
Vascular disorders
Hot flush
|
48.9%
67/137 • Number of events 69 • 336 days
|
|
Vascular disorders
Hypertension
|
14.6%
20/137 • Number of events 23 • 336 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information from the trial is property of the Sponsor and the PI has no right on it except the prior writing authorization of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER