Clinical Trials Register

Summary
EudraCT Number:	2015-002867-41
Sponsor's Protocol Code Number:	OPS-C-001/D-FR-01072-001
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	GB - no longer in EU/EEA
Date on which this record was first entered in the EudraCT database:	2016-03-31
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

UK - MHRA

A.2

EudraCT number

2015-002867-41

A.3

Full title of the trial

An international multi-center, open-label study to evaluate safety,
tolerability, biodistribution, dosimetry and preliminary efficacy of 177Lu-
OPS201 for the therapy of somatostatin receptor positive neuroendocrine
tumours (NETs).

A.3.1

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

An international multi-center, open-label study to evaluate safety,
tolerability, biodistribution (distribution in the body), dosimetry (to
calculate the radiation exposure of patients) and preliminary efficacy of
177Lu-OPS201 for the therapy of somatostatin receptor positive
neuroendocrine tumours (NETs).

A.4.1

Sponsor's protocol code number

OPS-C-001/D-FR-01072-001

A.5.4

Other Identifiers

Name:

ClinicalTrials.gov Identifier (NCT number)

Number:

NCT02592707

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
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
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 Pharma
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	65 quai Georges Gorse
B.5.3.2	Town/ city	Boulogne-Billancourt
B.5.3.3	Post code	92100
B.5.3.4	Country	France
B.5.4	Telephone number	+3316092 20 00
B.5.5	Fax number	+3316907 28 02
B.5.6	E-mail	ct-application@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	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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	250 to 350
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	Yes
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.IMP: 2
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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	250 to 350
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	Yes
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.IMP: 3
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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	250 to 350
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	Yes
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.IMP: 4
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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	550 to 850
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	Yes
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.IMP: 5
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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	550 to 850
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	Yes
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.IMP: 6
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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	550 to 850
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	Yes
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.IMP: 7
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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1100 to 1500
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	Yes
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.IMP: 8
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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1100 to 1500
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	Yes
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.IMP: 9
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	177Lu-OPS201 - 177Lu-satoreotide tetraxetan
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	LUTETIUM, ISOTOPE OF MASS 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	GBq gigabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	satoreotide tetraxetan
D.3.9.1	CAS number	1039726-31-2
D.3.9.2	Current sponsor code	OPS201
D.3.9.3	Other descriptive name	OPS201
D.3.9.4	EV Substance Code	SUB182340
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1100 to 1500
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	Yes
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

Neuroendocrine tumors (NETs)

E.1.1.1

Medical condition in easily understood language

Neuroendocrine tumors (NETs), neoplasms that arise from cells of the
endocrine (hormonal) and nervous systems.

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10052399
E.1.2	Term	Neuroendocrine tumour
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the safety and tolerability of peptide receptor radionuclide
therapy (PRRT) with 177Lu-OPS201 administered in three cycles in
patients with somatostatin receptor (sstr) 2 positive NETs (including
phaechromocytomas and paragangliomas).

E.2.2

Secondary objectives of the trial

•To evaluate the optimal radioactivity and peptide mass dose to be used
in future studies
•To characterize 177Lu-OPS201 whole body biodistribution and
pharmacokinetics of the radiopharmaceutical after each administration
of 177Lu-OPS201.
•To determine the radiation dosimetry of 177Lu-OPS201 (organ
exposure to administered radioactivity) after each administration of 177Lu-OPS201 with three different peptide mass doses.
•To undertake a preliminary assessment of the therapeutic efficacy of
177Lu-OPS201 PRRT by determination of RECIST v1.1 status. The
progression free survival (PFS) will be evaluated in Long-term Follow-up
Visits up to 2 years after the end of core-trial (EOCT) Visit.
• To evaluate the response to treatment by assessing changes in tumour volume.
•To evaluate the influence of 177Lu-OPS201 PRRT on the subject´s Quality of Life.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent
2. Subjects of either gender, aged ≥ 18 years
3. Women of childbearing potential (not surgically sterile or less than 2
years postmenopausal) must use a medically accepted method of
contraception and must agree to continue use of this method for the
duration of the study and for 6 months after the last dose. Acceptable
methods of contraception include abstinence, or double contraception:
steroidal contraceptive (oral, transdermal, implanted, and injected) in
conjunction with a barrier method (intrauterine device, condom etc.).
4. Male subjects must use a medically accepted method of contraception
and must agree to continue use of this method for the duration of the
study and for 6 months after the last activity administration.
5. Karnofsky performance score ≥ 60
6. Life expectancy of at least 6 months
7. Histologically confirmed diagnosis of
- unresectable GEP NET (Grade I and Grade II according to WHO
classification (2010), functioning and nonfunctioning)
- unresectable "typical lung carcinoid" or "atypical lung carcinoid" are
acceptable (with the exception of Large Cell Bronchial Neuroendocrine
Neoplasms and Small Cell Lung Cancers) (Caplin 2015).
- malignant, unresectable pheochromocytoma or paraganglioma
- subjects, who have histologically confirmed NET, but no clear localization of their primary tumor can be included.
8. Documentation of progressive disease based on RECIST v1.1 under prior anti-tumor therapy within 6 months of Visit 1 Day 1 (although the progression might have occurred more than 6 months before Visit 1 Day1). Subjects should not have received further anti-tumor therapy
once disease progression is documented. All images should be sent to the imaging core laboratory. 9. In countries where sunitinib or everolimus are marketed, patients
with GEP NET and lung NET will be progressive under this prior antitumor
treatment for the respective indication. Subjects not suitable for
everolimus/sunitinib therapy according to a tumor board decision (or
comparable local practice) may also be enrolled into the study. Subjects having everolimus/sunitinib therapy should have a wash-out phase of ≥
4 weeks before the first treatment.
10. Measurable disease based on RECIST v1.1.
11. For Part A: Confirmed presence of somatostatin receptors on technically evaluable tumor lesions documented by a positive SRS* performed within 6 months prior of Visit 1 Day 1

* presence of at least one lesion that is ≥ 20 mm in the longest dimension (as measured on correlative CT or MRI) and with a maximum Standardized Uptake Value (SUVmax) of ≥ 2x the SUVmean of the liver background on 68Ga-PET imaging or a score of "3" or "4" according to the Krenning scale on 111In-SPECT Imaging.

For Part B: Confirmed presence of sstr on technically evaluable tumour lesions documented by a positive SRS*. If this has not been performed within 6 months of Visit 1 Day 1, then it must be repeated during screening.

*presence of at least two lesions that are ≥20 mm in the longest Dimension (as measured on correlative CT or MRI) with a maximum standardised uptake value (SUVmax) of ≥2× the SUVmean of the liver background on 68Ga-PET imaging or a score of "3" or "4" according to
the Krenning scale on SPECT Imaging.

12. Calculated glomerular filtration rate (GFR) ≥ 55 mL/min
13. Blood test results as follows:
a. Leukocytes: ≥ 4*10^9/L
b. Erythrocytes: ≥ 3.5*10^12/L
c. Platelets: ≥ 100*10^9/L
d. Albumin: > 30 g/L
e. ALT, AST, AP: ≤ 5 times upper limit of normal (UNL)
f. Bilirubin: ≤ 3 times ULN (2x 1.1 mg/dL)

E.4

Principal exclusion criteria

1. Known hypersensitivity to 177Lu, DOTA, JR11 or to any of the
excipients of 177Lu-OPS201.
2. Any previous PRRT.
3. Diagnosis of thymic NET.
4. Presence of active infection at screening, or history of serious
infection within the previous 6 weeks.
5. Administration of any other investigational medicinal product (IMP)
within 60 days prior to entry (Visit 1 Day 1).
6. Prior or planned administration of a therapeutic radiopharmaceutical
within 8 half-lives of the radionuclide including any time during the
current study.
7. Any extensive radiotherapy ≤ 3 months before first IRPP administration.
8. Chemotherapy ≤ 3 months before first IMP administration.
9. For Part B: Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject at high risk of renal toxicity during the study
as assessed by the investigator
10a. Pregnant or breast-feeding women. A serum pregnancy test will be performed
at the start of the study for all female subjects of childbearing potential
(i.e. not surgically sterile or up to 2 years postmenopausal).
11. Any uncontrolled significant medical, psychiatric or surgical condition (active infection (including subject with known hepatitis B or
hepatitis C and subjects with known human immunodeficiency virus
(HIV) positive), unstable angina pectoris, cardiac arrhythmia,
poorly controlled hypertension, poorly controlled diabetes mellitus(glycated haemoglobin (HbA1c) ≥9%), uncontrolled congestive heart disease, etc.) or
laboratory findings that, in the opinion of the investigator, might
jeopardize the subject's safety or that would limit compliance with the
objectives and assessments of the study. Note: the subject should be
able to tolerate high volume load.
12. Current history of any malignancy other than NET within 5 years of
enrolment except for fully-resected non-melanoma skin cancer or
cervical cancer in situ
13. Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence
of an uncooperative attitude.

E.5 End points

E.5.1

Primary end point(s)

Safety and Tolerability
(Frequency and/or descriptive summaries of standard safety and
tolerability parameters: AEs (including SAEs) according to National Cancer Institute (NCI) common terminology criteria for adverse Events (CTCAE) v5.0 and serious adverse events (SAEs), vital signs, laboratory tests (haematology, biochemistry and urinalysis, and pituitary markers),
12 lead and Holter electrocardiogram (ECG), DLTs, physical examination
results and use of concomitant medication throughout the study.

E.5.1.1

Timepoint(s) of evaluation of this end point

At all visits during the study; SAE reporting during the whole course of the study subsequently after occurance. 24 hour holter ECG starting with each PRRT treatment procedure on Visit 1-3 day 1.

E.5.2

Secondary end point(s)

Biodistribution and Pharmacokinetics of the Radiopharmaceutical Endpoints:
• maximal uptake (%) at the target lesion
• maximal uptake (%) in discernible organs and blood
• AUC of 177Lu OPS201 in discernible thoracic and abdominal organs, target lesion and blood.
• Terminal half-life of radioactivity concentrations of the
radiopharmaceutical in blood.

Radiation Dosimetry Endpoints:
• Organs receiving the highest absorbed dose.
• Specific absorbed dose to the target lesion (Gy/GBq)
• Specific absorbed dose per organ (Gy/GBq).
• Cumulative absorbed organ doses (Gy).

OPS201 Pharmacokinetics Endpoints:
• If OPS201 levels are measurable in plasma and urine, pharmacokinetic
parameters of OPS201 (including, but not limited to, Cmax, AUC, t1/2,
CL, Vd, cumulative amount of unchanged drug excreted into the urine
(Ae) and renal clearance of the drug from plasma (CLR)) will be derived
using a non-compartmental approach on the individual plasma
concentration-time profiles of OPS201 and on the individual urine
concentrations.
An attempt to build an integrated model taking into account PK,
dosimetry as well as efficacy and safety data will be made if warranted
by the data.

Secondary Efficacy Endpoints
• Objective tumour response based on RECIST v1.1 (CT/MRI scan) by
calculating best overall response (BOR), overall response rate (ORR) and disease control rate (DCR);
• PFS based on RECIST v1.1.

Influence of 177Lu-OPS201 PRRT on the Quality of Life:
• Quality of Life Questionnaire (QLQ-C30; GI.NET21) change from baseline to EOCT

E.5.2.1

Timepoint(s) of evaluation of this end point

Biodistribution and Pharmacokinetics:
After each PRRT-cycle

Radiation Dosimetry:
After each PRRT-cycle

Pharmacokinetics:
After each PRRT-cycle

Preliminary Therapeutic Efficacy (tumor response)
Screening visit, each cycle of therapy, EOCT
visit, each long-term FU visit

Influence of 177Lu-OPS201 PRRT on the Quality of Life of the patients
At Visit 1,2,3 and EOCT visit

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

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Radiation Dosimetry of 177Lu-OPS201

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

First sponsor initiated clinical phase I/II trial

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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.8.3

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

Australia

Austria

Canada

Denmark

France

Switzerland

United Kingdom

United States

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

Last long-term follow-up visit of the last patient

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:

F.2 Gender

F.2.1

Female

Yes

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

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. At the discretion of the treating physician.

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

2016-05-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-05-23

P. End of Trial
P.	End of Trial Status	GB - no longer in EU/EEA

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Select Trial Status:	Select Trial Phase:
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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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