Trial Outcomes & Findings for Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer (NCT NCT03261999)

NCT ID: NCT03261999

Last Updated: 2020-05-04

Results Overview

The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 144 participants
• Primary outcome timeframe: 168 days
• Results posted on: 2020-05-04

Participant Flow

Participant milestones

Measure	Leuprolide Mesylate 25mg Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate. The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168. Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate
Overall Study STARTED	144
Overall Study ITT	144
Overall Study PP	132
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

Baseline characteristics by cohort

Measure	Leuprolide Mesylate 25mg n=144 Participants Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate. The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168. Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate
Age, Continuous	69.8 years STANDARD_DEVIATION 7.93 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	136 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 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	1 Participants n=5 Participants
Race (NIH/OMB) White	127 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment South Korea	16 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants
Region of Enrollment Czechia	9 Participants n=5 Participants
Region of Enrollment Slovakia	34 Participants n=5 Participants
Region of Enrollment Lithuania	77 Participants n=5 Participants
Diagnosis (days) of prostate carcinoma history	842.7 days STANDARD_DEVIATION 1348.9 • n=5 Participants

PRIMARY outcome

Timeframe: 168 days

Population: ITT (one subject had missing time point at Day 28)

The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168.

Outcome measures

Measure	Leuprolide Mesylate 25mg n=143 Participants Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate. The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168. Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate
Efficacy of Leuprolide Mesylate (LMIS 25mg)	97.9 Percentage of participants Interval 93.5 to 99.3

SECONDARY outcome

Timeframe: 168 days

Population: Safety population

Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).

Outcome measures

Measure	Leuprolide Mesylate 25mg n=144 Participants Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate. The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168. Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate
Number of Participants With Adverse Events TEAE	90 subjects
Number of Participants With Adverse Events Drug-related TEAE	53 subjects
Number of Participants With Adverse Events SAE	9 subjects

Adverse Events

Leuprolide Mesylate 25mg

Serious events: 9 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Measure	Leuprolide Mesylate 25mg n=144 participants at risk Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate. The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168. Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate
Cardiac disorders Acute myocardial infarction	0.69% 1/144 • Number of events 1 • 168 days
Gastrointestinal disorders Pancreatitis acute	0.69% 1/144 • Number of events 1 • 168 days
Hepatobiliary disorders Drug-induced liver injury	0.69% 1/144 • Number of events 1 • 168 days
Injury, poisoning and procedural complications Tendon rupture	0.69% 1/144 • Number of events 1 • 168 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.69% 1/144 • Number of events 1 • 168 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal neoplasm	0.69% 1/144 • Number of events 1 • 168 days
Nervous system disorders Cerebrovascular accident	0.69% 1/144 • Number of events 1 • 168 days
Nervous system disorders Sciatica	0.69% 1/144 • Number of events 1 • 168 days
Renal and urinary disorders Urethral stenosis	0.69% 1/144 • Number of events 1 • 168 days
Surgical and medical procedures Rehabilitation therapy	0.69% 1/144 • Number of events 1 • 168 days

Other adverse events

Measure	Leuprolide Mesylate 25mg n=144 participants at risk Subjects were injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate. The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects were followed until day 168. Leuprolide Mesylate: Subcutaneous injection of 25mg Leuprolide Mesylate
Vascular disorders hot flush	24.3% 35/144 • Number of events 35 • 168 days
Vascular disorders Hypertension	11.1% 16/144 • Number of events 18 • 168 days
Investigations weight increased	7.6% 11/144 • Number of events 11 • 168 days
General disorders Injection site haemorrhage	5.6% 8/144 • Number of events 9 • 168 days

Additional Information

John Mao

Foresee Pharmaceuticals Co., Ltd

Phone: +886 2-7750-0188

Email: john.mao@foreseepharma.com

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