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The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

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Clinical Trial Results:
An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects with Advanced Prostate Carcinoma

Summary
EudraCT number	2013-001790-25
Trial protocol	AT DE CZ SK LT PL
Global end of trial date	02 Sep 2016

Results information
Results version number	v2(current)
This version publication date	22 Apr 2020
First version publication date	27 Oct 2018
Other versions	v1
Version creation reason	Correction of full data set Version 2 contains the same data as version 1. Version 2 was created in order to correct IT issues.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

FP01C-13-001

ISRCTN number

-

US NCT number

NCT02234115

WHO universal trial number (UTN)

-

Sponsor organisation name

Foresee Pharmaceuticals Co., Ltd

Sponsor organisation address

3F., No. 19-3, Sanchong Rd., Nangang Dist., Taipei City, Taiwan, 115

Public contact

Clinical Trials Information, QPS Austria, 0043 316258111,

Scientific contact

Clinical Trials Information, QPS Austria, 0043 316258111,

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

13 Feb 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

30 Aug 2016

Global end of trial reached?

Yes

Global end of trial date

02 Sep 2016

Was the trial ended prematurely?

No

Main objective of the trial

Primary objectives: 1. Determine the safety and tolerability of LMIS 50 mg for up to 1 year of exposure following 2 subcutaneous doses given at 6 months apart in subjects with advanced prostate carcinoma; 2. Establish the efficacy of LMIS 50 mg for up to 1 year following 2 subcutaneous doses given at 6 months apart in subjects with advanced prostate carcinoma, as determined by the magnitude and duration of suppression of serum testosterone levels; and 3. Evaluate the pharmacokinetic behavior of serum leuprolide following 2 subcutaneous injections of LMIS 50 mg given 6 months apart.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the countries in which a study is conducted.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

01 Jul 2014

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 5

Country: Number of subjects enrolled

Slovakia: 18

Country: Number of subjects enrolled

Austria: 1

Country: Number of subjects enrolled

Czech Republic: 17

Country: Number of subjects enrolled

Germany: 1

Country: Number of subjects enrolled

Lithuania: 29

Country: Number of subjects enrolled

United States: 64

Country: Number of subjects enrolled

Taiwan: 2

Worldwide total number of subjects

137

EEA total number of subjects

71

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

45

From 65 to 84 years

82

85 years and over

10

Subject disposition

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Recruitment details

-

Screening details

Male adult subjects with histologically confirmed prostate carcinoma were screened based on baseline morning serum testosterone level , ECOG performance, lab chemistry results for lipid profile, serum glucose, HgbA1c, clinical chemistries (K, Na, Mg, Ca and P), and urinalysis range.

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

LMIS 50 mg

Arm description

-

Arm type

Experimental

Investigational medicinal product name

LMIS 50 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

LMIS 50 mg was given SC once every 24 weeks for up to 1 years.

Number of subjects in period 1	LMIS 50 mg
Started	137
Completed	122
Not completed	15
Adverse event, serious fatal	3
Consent withdrawn by subject	3
Disease progression	1
Adverse event, non-fatal	2
Lost to follow-up	1
Lack of efficacy	1
Protocol deviation	4

Baseline characteristics

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Reporting group title

Overall trial

Reporting group description

-

Reporting group values	Overall trial	Total
Number of subjects	137	137
Age categorical
Units: Subjects
Adults (18-64 years)	45	45
From 65-84 years	82	82
85 years and over	10	10
Gender categorical
Units: Subjects
Female	0	0
Male	137	137
Ethnicity
Units: Subjects
Hispanic or Latino	3	3
Not Hispanic or Latino	61	61
Unknown or Not Reported	73	73
Race
Units: Subjects
American Indian or Alaska Native	0	0
Asian	5	5
Native Hawaiian or Other Pacific Islander	0	0
Black or African American	8	8
White	123	123
More than one race	0	0
Unknown or Not Reported	1	1
Region of Enrollment
Units: Subjects
Austria	1	1
United States	64	64
Czech Republic	17	17
Taiwan	2	2
Poland	5	5
Slovakia	18	18
Lithuania	29	29
Germany	1	1

End points

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Reporting group title

LMIS 50 mg

Reporting group description

-

Subject analysis set title

Full analysis

Subject analysis set type

Intention-to-treat

Subject analysis set description

Any subject who received at least one dose of LMIS 50 mg was included in the analysis.

Primary: Proportion of subjects with a serum testosterone concentration suppressed to castrate levels from Day 28 through Day 336

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End point title

Proportion of subjects with a serum testosterone concentration suppressed to castrate levels from Day 28 through Day 336 ^[1]

End point description

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).

End point type

Primary

End point timeframe

Baseline to 28 days, 28 days to 336 days

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are sufficient for this single-arm study.

End point values	LMIS 50 mg
Number of subjects analysed	137
Units: Percentage
arithmetic mean (confidence interval 95%)	97.0 (92.2 to 98.9)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

336 days

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

All subjects

Reporting group description

-

Serious adverse events	All subjects
Total subjects affected by serious adverse events
subjects affected / exposed	20 / 137 (14.60%)
number of deaths (all causes)	3
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Colon cancer
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Vascular disorders
Intermittent claudication
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Peripheral artery occlusion
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Death
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Non-cardiac chest pain
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Asthma
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Injury, poisoning and procedural complications
Hip fracture
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Joint dislocation
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Subdural haematoma
subjects affected / exposed	2 / 137 (1.46%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Atrial fibrillation
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Myocardial infarction
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 1
Metabolic encephalopathy
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Eye disorders
Vision blurred
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Dysphagia
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Skin and subcutaneous tissue disorders
Diabetic foot
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Bronchitis bacterial
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Clostridium difficile colitis
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Pneumonia
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 137 (0.73%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 0.05%

Non-serious adverse events	All subjects
Total subjects affected by non serious adverse events
subjects affected / exposed	114 / 137 (83.21%)
Vascular disorders
Hot flush
subjects affected / exposed	67 / 137 (48.91%)
occurrences all number	69
Hypertension
subjects affected / exposed	20 / 137 (14.60%)
occurrences all number	23
General disorders and administration site conditions
Fatigue
subjects affected / exposed	9 / 137 (6.57%)
occurrences all number	10
Injection site pain
subjects affected / exposed	10 / 137 (7.30%)
occurrences all number	13
Renal and urinary disorders
Nocturia
subjects affected / exposed	8 / 137 (5.84%)
occurrences all number	9
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	9 / 137 (6.57%)
occurrences all number	12
Back pain
subjects affected / exposed	7 / 137 (5.11%)
occurrences all number	7
Pain in extremity
subjects affected / exposed	13 / 137 (9.49%)
occurrences all number	18
Infections and infestations
Nasopharyngitis
subjects affected / exposed	7 / 137 (5.11%)
occurrences all number	9

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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