Clinical Trials Register

Summary
EudraCT Number:	2021-005719-29
Sponsor's Protocol Code Number:	D-FR-52014-245
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-06-08
Trial 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

Czechia - SUKL

A.2

EudraCT number

2021-005719-29

A.3

Full title of the trial

An open-label, multicentre, single arm study to assess the efficacy and safety of triptorelin 6-month formulation administered subcutaneously in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue

Otevřená, multicentrická, jednoramenná studie zaměřená na hodnocení účinnosti a bezpečnosti přípravku triptorelin v šestiměsíční formě podávaného subkutánně u účastníků s lokálně pokročilým a/nebo metastázujícím karcinomem prostaty, kteří byli dříve léčeni a farmakologicky kastrováni analogem GnRH

A.3.1

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

Effects of triptorelin when given every 6-months under the skin to adult males with cancer in the prostate

Účinky přípravku triptorelin při podávání každých 6 měsíců pod kůži dospělým mužům s nádorovým onemocněním prostaty

A.4.1

Sponsor's protocol code number

D-FR-52014-245

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	Ipsen Pharma SAS
B.1.3.4	Country	France
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	Ipsen Pharma SAS
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Ipsen Bioscience, Inc.
B.5.2	Functional name of contact point	Senior Med. Development Director
B.5.3	Address:
B.5.3.1	Street Address	1 Main Street
B.5.3.2	Town/ city	Cambridge, Massachusetts
B.5.3.3	Post code	02142
B.5.3.4	Country	United States
B.5.6	E-mail	jaroslaw.jac@ipsen.com

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	Yes
D.2.1.1.1	Trade name	Decapeptyl
D.2.1.1.2	Name of the Marketing Authorisation holder	Ipsen Pharmaceuticals Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
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	TRIPTORELIN
D.3.9.1	CAS number	57773-63-4
D.3.9.3	Other descriptive name	Triptorelin embonate (pamoate)
D.3.9.4	EV Substance Code	SUB11324MIG
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	22.5
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	Yes
D.3.11.13.1	Other medicinal product type	Triptorelin is an agonist analogue of natural GnRH.

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

Prostate cancer

E.1.1.1

Medical condition in easily understood language

Prostate cancer

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	24.1
E.1.2	Level	LLT
E.1.2	Classification code	10085679
E.1.2	Term	Locally advanced prostate cancer
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

To evaluate the efficacy of triptorelin
embonate 22.5 mg 6-month formulation
administered subcutaneously in maintaining
serum testosterone castrate levels in
participants with advanced prostate cancer
previously treated and castrated with a
GnRH analogue.

E.2.2

Secondary objectives of the trial

- To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation
administered subcutaneously on castration;
- To evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation
administered subcutaneously on testosterone levels <0.694 nmol/L (20 ng/dL);
- To demonstrate the effect of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously to suppress the ‘acute-on-chronic’ effect following the administration of the second dose;
- To demonstrate the effect of triptorelin embonate 22.5 mg 6-month formulation administered subcutaneously in the maintenance of PSA;
- To demonstrate the safety profile of triptorelin embonate 22.5 mg 6-month
formulation administered subcutaneously;

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participant is male and must be 18 years of age inclusive, at the time of signing the informed consent.
2. Participant has histologically or cytologically proven prostate cancer with rising PSA after failed local therapy or metastatic disease, or requiring radiotherapy, and be a candidate for long-term (i.e. >1 year) androgen deprivation therapy.
3. Participant requires a GnRH analogue treatment for a minimum of 18 months, of which a minimum of 3 months of GnRH analogue treatment has already been provided prior to screening. (Note: participants must receive study intervention on Day 1 in accordance with the treatment schedule of their previously received GnRH analogue therapy).
4. Has serum testosterone levels <1.735 nmol/L (50 ng/dL) at screening.
5. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 (see Appendix 10.4).
6. Has a life expectancy of >18 months.
7. Male participants must agree that, if their partner is at risk of becoming pregnant (although highly unlikely in this study population), they will use an effective method of contraception. The participant must agree to use the contraception during the whole of the study and for 9 months after the last dose of study intervention.
8. Capable of giving signed informed consent as described in Appendix 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

E.4

Principal exclusion criteria

Medical conditions
1.Presence of another neoplastic lesion or brain metastases.
2.Metastatic hormone-sensitive prostate cancer with high tumour burden
3.Metastatic castration-resistant prostate cancer
4.Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance or with the study in the opinion of the investigator.
Prior/concomitant therapy
5.Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the past 6 months
6.Planned intermittent scheme of GnRH analogue
7.At the time of screening, planned use of any chemotherapy for prostate cancer during the study
8.Prior hypophysectomy or adrenalectomy
Prior/concurrent clinical study experience
9.Participation in another study with an experimental drug within 3 months before signing informed consent or within five half-lives of the investigational drug (whichever was the longer), or any other type of medical research.
Diagnostic assessments
10.Severe kidney or liver failure (creatinine >2 times the normal range, aspartate aminotransferase and alanine aminotransferase >3 times the normal range)
Other exclusions
11.Any concomitant disorder or resulting therapy that is likely to interfere with participant’s compliance, the subcutaneous administration of the drug or with the study in the opinion of the investigator.
12.Previous history of QT prolongation or concomitant use of medicinal products known to prolong the QT interval or with a known risk of torsades de pointes
13.Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues.
14.Known active use of recreational drug or alcohol dependence in the opinion of the investigator
15.Inability to give informed consent or to comply fully with the protocol.

E.5 End points

E.5.1

Primary end point(s)

Percentage of participants maintaining castrate levels of serum testosterone during
the study (maintenance of castration defined as testosterone <1.735 nmol/L (50 ng/dL) at Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337)

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.1

E.5.2

Secondary end point(s)

- Percentage of participants castrated at each
timepoint on Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337
(castration defined as testosterone <1.735 nmol/L (50 ng/dL)).
- Percentage of participants with a serum testosterone level <0.694 nmol/L (20 ng/dL) during the study.
- Percentage of participants with a serum testosterone level <0.69 nmol/L (20 ng/dL) at each timepoint on Day 29, Day 85, Day 141, Day 169, Day 253, Day 309 and Day 337.
- Percentage of participants castrated on Day 3 and Day 7 after each injection administered on Day 1 and Day 169 (castration defined as testosterone
<1.735 nmol/L (50 ng/dL)).
- Percent change in PSA from baseline (prior to injection) at Day 169 and Day 337 (Percent change in PSA defined as the absolute value of difference between the PSA values at Day 169 and Day 337 and the baseline value divided by the baseline value).
- Incidence of TEAEs (including local tolerability) throughout the study i.e. up to
Day 337.
- Change from baseline in clinical safety laboratory parameters (blood chemistry and haematology) at Day 337
- Change from baseline in physical examination at Day 169 and Day 337
- Change from baseline in ECG at Day 337
- Change from baseline in vital signs (blood pressure and heart rate) at each visit up to Day 337

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.2

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LPLV

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

E.8.9.2

In all countries concerned by the trial days

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:

122

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

145

F.4.2.2

In the whole clinical trial

145

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)

None

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-06-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-08-26

P. End of Trial
P.	End of Trial Status	Ongoing

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