Clinical Trial Results:
An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects with Prostate Cancer
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Summary
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EudraCT number |
2017-001333-88 |
Trial protocol |
LT SK CZ |
Global end of trial date |
02 Sep 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Mar 2021
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First version publication date |
17 Mar 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FP01C-17-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03261999 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Foresee Pharmaceuticals, Co., Ltd.
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Sponsor organisation address |
9F-2, No. 19-3, Sanchong Rd., Nangang Dist., Taipei, Taiwan,
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Public contact |
Yen-Ling Lin, Ph.D., Foresee Pharmaceuticals, Co., Ltd., yenling.lin@foreseepharma.com
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Scientific contact |
Yisheng Lee, Ph.D., Foresee Pharmaceuticals, Co., Ltd., yisheng.lee@foreseepharma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Sep 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Sep 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Sep 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the efficacy and safety of LMIS 25 mg for up to 24 weeks following 2 subcutaneous doses given 12 weeks apart in subjects with prostate cancer.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Sep 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Korea, Republic of: 16
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Country: Number of subjects enrolled |
United States: 8
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Country: Number of subjects enrolled |
Slovakia: 34
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Country: Number of subjects enrolled |
Czech Republic: 9
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Country: Number of subjects enrolled |
Lithuania: 77
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Worldwide total number of subjects |
144
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EEA total number of subjects |
120
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
37
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From 65 to 84 years |
103
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85 years and over |
4
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Recruitment
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Recruitment details |
EEA area: 120 subjects (September 2017 to May 2018), Republic of Korea: 16 subjects (January 2018 to May 2018), United States: 8 subjects (November 2017 to April 2018) | ||||||||||||||||
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Pre-assignment
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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. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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LMIS 25mg | ||||||||||||||||
Arm description |
Any subject who received at least one dose of LMIS 25 mg (Intention-To-Treat population N = 144). Thereof, subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) Day 28 (V9): n = 143 | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
LEUPROLIDE MESYLATE INJECTABLE SUSPENSION 25 mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Two separate doses of LMIS 25 mg with approx. 12-week apart
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
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End points reporting groups
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Reporting group title |
LMIS 25mg
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Reporting group description |
Any subject who received at least one dose of LMIS 25 mg (Intention-To-Treat population N = 144). Thereof, subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) Day 28 (V9): n = 143 | ||
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End point title |
Proportion of subjects with serum testosterone concentration suppressed to castrate levels from Day 28 through Day 168 [1] | ||||||||
End point description |
The primary endpoint of efficacy was to determine the percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) on Day 28 ± 1 day (week 4) following the first injection of LMIS 25 mg, and the proportion of subjects with serum testosterone suppression (≤ 50 ng/dL) from Day 28 ± 1 day (week 4) through Day 168 ± 5 days (week 24) until the end of the study. Note: Descriptive statistics are sufficient for this single-arm study, therefore no statistical analyses for this endpoint specified.
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End point type |
Primary
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End point timeframe |
Baseline to 28 days (week 4), 28 days to 168 days (week 24)
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| 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: This clinical study was open-label by design, therefore no comparison with a control group has been made. |
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Adverse events information
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Timeframe for reporting adverse events |
168 days per subject; Screening till End of Study Visit (Follow up for drop outs 12 weeks after last injection)
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Adverse event reporting additional description |
Subjects who were withdrawn due to AEs or SAEs have been be followed until these events were resolved or until the event was considered stable.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.1
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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02 Jan 2018 |
The protocol was revised because of administrative changes, changes for one of the exclusion criteria*, and correction for typos.
*Patients previously enrolled in the LMIS 50 mg study were not excluded in version 1.0. Thus, this criterion was added in version 1.1 as in Exclusion criteria (6) to avoid potential patient selection bias and for clarification. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Site CZ03 was found with significant GCP violation during the study conduct; thus, the sensitivity analysis for the primary efficacy endpoint excluding subjects from CZ03 was performed. | |||
