Clinical Trials Register

Summary
EudraCT Number:	2013-001790-25
Sponsor's Protocol Code Number:	FP01C-13-001
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-06-30
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2013-001790-25

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A clinical trial for advanced prostatic cancer patients . The study medication will be Leuprolide Mesylate, which will be administered as an injection twice. Both the study doctors and clinical trial participants know which treatment is being administered, there will be only one treatment group.
The safety and efficacy of the medicinal product will be tested during the study.

A.4.1

Sponsor's protocol code number

FP01C-13-001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Foresee Pharmaceuticals Co., Ltd.
B.1.3.4	Country	Taiwan
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Foresee Pharmaceuticals Co., Ltd.
B.4.2	Country	Taiwan
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	QPS Austria
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	Parkring 12
B.5.3.2	Town/ city	Grambach
B.5.3.3	Post code	8074
B.5.3.4	Country	Austria
B.5.4	Telephone number	0043316258111
B.5.5	Fax number	0043316258111300

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Leuprolide Mesylate for injectable suspension 50mg
D.3.2	Product code	LMIS 50 mg
D.3.4	Pharmaceutical form	Suspension for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUPROLIDE MESYLATE
D.3.9.2	Current sponsor code	LMIS 50 mg
D.3.9.3	Other descriptive name	LEUPROLIDE MESYLATE
D.3.9.4	EV Substance Code	SUB166604
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Advanced Prostate Carcinoma

E.1.1.1

Medical condition in easily understood language

Prostate Cancer, that has progressed over the past

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10036921
E.1.2	Term	Prostate carcinoma
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

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.

E.2.2

Secondary objectives of the trial

Secondary objectives are to characterize the effects of LMIS 50 mg on the ancillary laboratory markers of serum prostate specific antigen (PSA) and luteinizing hormone (LH).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria
(1) Males aged ≥ 18 years old
(2) Males with histologically confirmed carcinoma of the prostate
(3) Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy
(4) Baseline morning serum testosterone level >150 ng/dL
(5) ECOG Performance score ≤ 2
(6) Life expectancy of at least 18 months
(7) Laboratory values
o Absolute neutrophil count ≥ 1,500 cells/μL
o Platelets ≥ 100,000 cells/μL
o Hemoglobin ≥ 10 gm/dL
o Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
o AST (SGOT) ≤ 2.5 × ULN
o ALT (SGPT) ≤ 2.5 × ULN
o Serum creatinine ≤ 1.5 mg/dL
o Lipid profile within acceptable range according to investigator's opinion
o Serum glucose within acceptable range according to investigator's opinion
o HgbA1c within acceptable range according to investigator's opinion
o Clinical chemistries (K, Na, Mg, Ca and P) acceptable range according to investigator's opinion
o Urinalysis within normal range according to investigator's opinion
(8) Agree to use male contraceptive methods during study trial
(9) In the Investigator’s opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol
(10) All aspects of the protocol explained and written informed consent obtained

E.4

Principal exclusion criteria

Main exclusion criteria:
(1) Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy concomitantly, or within 8 weeks prior to Screening Visit, for treatment of carcinoma of the prostate. Radiation for pain control will be allowed during the study.
(2) Receipt of any vaccination (including influenza) within 4 weeks of Baseline
(3) History of blood donation within 2 months of Baseline
(4) History of anaphylaxis to any LH-RH analogues
(5) Receipt of any LHRH suppressive therapy within 6 months of Baseline
(6) Major surgery, including any prostatic surgery, within 4 weeks of Baseline
(7) History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases. Subjects at risk for spinal cord compression will be excluded.
(8) Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction
(9) History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
(10) History or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of Baseline
(11) Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator
(12) History of drug and/or alcohol abuse within 6 months of Baseline
(13) Contraindication to leuprolide or an LHRH agonist as indicated on package labeling
(14) Use of 5-alpha reductase inhibitor within the last 6 months of Baseline
(15) History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed if only oral hypoglycemic are required
(16) Use of systemic corticosteroids at a dose >10mg/d or anti-androgens
(17) Use of any investigational agent within 4 weeks of Baseline
(18) Use of any over-the-counter (OTC) medication within 4 weeks of Baseline except for those listed in the permitted Concomitant Treatment section.
(19) Uncontrolled intercurrent illness that would jeopardize the subject’s safety, interfere with the objectives of the protocol, or limit the subject’s compliance with study requirements, as determined by the Investigator in consultation with the Sponsor

E.5 End points

E.5.1

Primary end point(s)

Primary Endpoints
1. Determine the safety and tolerability by:
• Change in bone pain measurement (by VAS scale)
• Change in urinary pain measurement (by VAS scale)
• Change in urinary signs and symptoms (by AUA Symptom Score sheet)
• Change in vital signs (BP, HR, RR)
• Change in physical examinations (including weight)
• Assessment for local skin tolerability
• Change in lab data, including liver function (AST, ALT, ALP), renal function (BUN, SCr), complete blood count with platelets, clinical chemistries (K, Na, Mg, Ca and P), urinalysis, serum glucose, lipid profile (LDL, HDL, triglycerides) and HgbA1c
• Adverse event (AE) reporting
• Clinically significant changes in 12-lead resting electrocardiograms (ECGs) per the Investigator
2. Efficacy evaluation
• The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) within 28 days following the first injection of LMIS 50 mg and the percentage of subjects with serum testosterone suppression (≤ 50 ng/dL) from Day 28 through Day 336 (remaining duration of the study).
3. Evaluation of pharmacokinetics
• Pharmacokinetic behavior of leuprolide: full pharmacokinetic profiles from serum leuprolide concentrations in Part I subjects will be performed. Additional serum leuprolide concentration data will be collected during Part II. The pharmacokinetic behavior of leuprolide will be determined in subjects during in Part II on a more limited basis.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. safety and tolerability Endpoints: Visits 1-23
2. Efficacy evaluation: Visits 1-23
3. Evaluation of pharmacokinetics: Visits 2-23

E.5.2

Secondary end point(s)

Secondary Endpoints
1. The proportion of subjects exhibiting post-suppression excursions of serum testosterone to >50 ng/dL, either through “breakthrough” (i.e., episodes unrelated to LMIS 50 mg dosing), or through the “acute-on-chronic” phenomenon (i.e., related to the second dose of LMIS 50 mg)
2. Effect of LMIS 50 mg on serum PSA levels
3. Effect of LMIS 50 mg on serum LH levels

E.5.2.1

Timepoint(s) of evaluation of this end point

1. The proportion of subjects exhibiting post-suppression excursions of serum
testosterone: Visits 2-23
2. Effect of LMIS 50 mg on serum PSA levels: Visits 2-23
3. Effect of LMIS 50 mg on serum LH levels: Visits 2-23

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Austria

Czech Republic

Germany

Lithuania

Poland

Slovakia

Taiwan

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

123

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

133

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients who complete the study will further treated in accordance with the current medical standards.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-10-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-09-02

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