Clinical Trials Register

Summary
EudraCT Number:	2019-002190-66
Sponsor's Protocol Code Number:	HS-19-647
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-07-26
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

Spain - AEMPS

A.2

EudraCT number

2019-002190-66

A.3

Full title of the trial

A Phase 3, open-label, single-arm, multi-center trial to assess the long term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

Ensayo en fase 3, abierto, de grupo único y multicéntrico, para evaluar la seguridad a largo plazo de octreotida (CAM2029) subcutánea de liberación prolongada en pacientes con acromegalia

A.3.1

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

A trial to assess the long-term safety of octreotide subcutaneous depot in patients with acromegaly

Ensayo para evaluar la seguridad a largo plazo de octreotide de liberación prolongada en pacientes con acromegalia

A.4.1

Sponsor's protocol code number

HS-19-647

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	Camurus AB
B.1.3.4	Country	Sweden
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	Camurus AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Accelsiors CRO and Consultancy Services Ltd
B.5.2	Functional name of contact point	regulatory unit
B.5.3	Address:
B.5.3.1	Street Address	103 Haros Str
B.5.3.2	Town/ city	Budapest
B.5.3.3	Post code	1222
B.5.3.4	Country	Hungary
B.5.4	Telephone number	+3612990091
B.5.5	Fax number	+3612990096
B.5.6	E-mail	regulatory@accelsiors.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/645
D.3 Description of the IMP
D.3.1	Product name	CAM2029 (Octreotide subcutaneous depot)
D.3.2	Product code	CAM2029
D.3.4	Pharmaceutical form	Prolonged-release solution 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	octreotide
D.3.9.2	Current sponsor code	CAM2029
D.3.9.3	Other descriptive name	OCTREOTIDE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB192677
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	Yes
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.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/645
D.3 Description of the IMP
D.3.1	Product name	CAM2029 (Octreotide subcutaneous depot)
D.3.2	Product code	CAM2029
D.3.4	Pharmaceutical form	Prolonged-release solution 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	octreotide
D.3.9.2	Current sponsor code	CAM2029
D.3.9.3	Other descriptive name	OCTREOTIDE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB192677
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	Yes
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

Acromegaly

Acromegalia

E.1.1.1

Medical condition in easily understood language

Acromegaly is a chronic metabolic disorder in which there is too much
growth hormone and the body tissues gradually enlarge.

La acromegalia es un trastorno metabólico crónico en el que hay excesiva secreción de la hormona del crecimiento y los tejidos del cuerpo aumentan
gradualmente

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10000599
E.1.2	Term	Acromegaly
E.1.2	System Organ Class	10014698 - Endocrine disorders

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 overall safety and tolerability of CAM2029

• Evaluar la seguridad y tolerabilidad generales de CAM2029

E.2.2

Secondary objectives of the trial

To assess efficacy of CAM2029 based on biochemical characteristics.
To assess self-and partner administration
To assess plasma concentration of octreotide after administration of CAM2029

• Evaluar la eficacia de CAM2029 sobre la respuesta bioquímica
• Evaluar la autoadministración supervisada o la administración por un colaborador
• Evaluar las concentraciones plasmáticas de octreotida tras la administración de CAM2029

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Male or female patients > =18 years at screening
Able to provide written informed consent to participate in the trial
Diagnosis of acromegaly by historical evidence (persistent or recurrent) acromegaly
Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
IGF-1 levels >1xULN and ≤1.3xULN at screening or IGF-1 levels <=1xULN at screnning with prior pituitary radiotherapy
Adequate liver, pancreatic, renal and bone marrow f unctions
Normal ECG

Pacientes mayor o igual a 18 años al Screening
- Pacientes con la capacidad suficiente para firmar el consentimiento informado del estudio y realizar los procedimientos del mismo.
-Diagnóstico de acromegalia (persistente o recidivante)
-Tratamiento con una dosis estable de octreotida LP (10 mg, 20 mg, 30 mg o 40 mg) o lanreotida ATG (60 mg, 90 mg o 120 mg) durante al menos 3 meses en monoterapia antes de la selección
-Niveles de IGF-1 # 1 x LSN, según el valor medio de una primera medición realizada en la selección y una segunda medición 2 semanas antes del día 1
-Funciones hepática, pancreática, renal y medular adecuadas
-ECG normal

E.4

Principal exclusion criteria

For Roll-over Patients from Trial HS-18-633:
• Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633)
• Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
For New Patients:
• Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer])
• Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
• Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
• Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening
• Patients who have undergone pituitary surgery within 6 months prior to screening
• Patients who have received prior pituitary irradiation within 3 years prior to screening
• Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)

Para los pacientes transferidos del ensayo HS-18-633
• Acontecimientos adversos graves (AAG) no resueltos relacionados con el fármaco en el ensayo anterior (HS-18-633)
• Pacientes con una situación médica o quirúrgica clínicamente significativa o inestable que pueda comprometer la participación segura y completa en el ensayo

Criterios principales de inclusión
Para los pacientes transferidos del ensayo HS-18-633
• Pacientes que asistan a la visita de la semana 24 del ensayo anterior (HS 18 633) y estén dispuestos a continuar su participación en este ensayo.
Para pacientes nuevos
• Diagnóstico de acromegalia (persistente o recidivante) documentado mediante:
o Niveles de IGF-1 > 1 x LSN
o Adenoma hipofisario detectado mediante resonancia magnética (RM) o tomografía computarizada (TC), si no se ha podido realizar RM
o Niveles de IGF-1 > 1 x LSN medidos al menos 3 meses después de la intervención quirúrgica en pacientes sometidos a cirugía hipofisaria
• Tratamiento con una dosis estable de octreotida LP (10 mg, 20 mg, 30 mg o 40 mg) o lanreotida ATG (60 mg, 90 mg o 120 mg) durante al menos 3 meses en monoterapia antes de la selección
• Niveles de IGF-1 > 1 x LSN e ≤ 1,3 x LSN en la visita de selección, con o sin radioterapia hipofisaria previa (como mínimo 3 años antes de la visita de selección),
o
Niveles de IGF-1 ≤ 1 x LSN en la visita de selección, con radioterapia hipofisaria 3 años antes, como mínimo, de la visita de selección y actividad confirmada de la enfermedad definida por niveles de IGF-1 > 1 x LSN durante el descanso del fármaco de 3 a 9 meses antes de la visita de selección.
• Funciones hepática, pancreática, renal y medular adecuadas
• ECG normal
Criterios principales de exclusión
Para los pacientes transferidos del ensayo HS-18-633
• Acontecimientos adversos graves (AAG) no resueltos relacionados con el fármaco en el ensayo anterior (HS-18-633)
• Pacientes con una situación médica o quirúrgica clínicamente significativa o inestable que pueda comprometer la participación segura y completa en el ensayo
Para pacientes nuevos
• Haber recibido tratamiento médico para la acromegalia con pasireotida (en los 6 meses anteriores a la selección), pegvisomant (en los 3 meses anteriores a la selección), agonistas dopaminérgicos (en los 3 meses anteriores a la selección) u otros fármacos en investigación (en los 30 días o 5 semividas antes de la selección [lo que sea más largo])
• Pacientes que toman habitualmente octreotida LP o lanreotida ATG con un frecuencia inferior a cada 4 semanas (p. ej., cada 6 o cada 8 semanas)
• Pacientes con compresión del quiasma óptico que provoque algún defecto del campo visual y en los que esté indicada la cirugía
• Pacientes sometidos a tratamiento quirúrgico/cirugía mayor por cualquier causa en el plazo de 1 mes antes de la selección
• Pacientes sometidos a cirugía hipofisaria en los 6 meses anteriores a la selección
• Pacientes sometidos a una irradiación hipofisaria previa en los 3 años anteriores a la selección
• Pacientes con diabetes mellitus mal controlada (hemoglobina A1c > 8,0 %)

E.5 End points

E.5.1

Primary end point(s)

• Characterization of adverse events (AEs)

- Determinación de Acontecimientos Adversos.

E.5.1.1

Timepoint(s) of evaluation of this end point

52 weeks

52 semanas

E.5.2

Secondary end point(s)

• Proportion of patients with mean IGF-1 levels ≤1 x upper limit of
normal (ULN) and ≤1.3xULN at Week 50 and Week 52
• Proportion of patients with mean GH levels <2.5 μg/L and <5.0 μg/L at Week 50 and Week 52
- Proportion of patients/partners declared competent by healthcare professional to administer CAM2029
- Octreotide plasma concentrations over time

-Proporción de pacientes con respuesta bioquímica, definida como unos niveles medios de IGF-1 # 1 x LSN en la semana 50 y la semana 52.
-Proporción de pacientes con niveles medios de GH < 2,5 μg/l en la semana 50 y la semana 52 -Proporción de pacientes/colaboradores declarados aptos por el profesional sanitario para administrar el CAM2029 o placebo.
-Incidencia de eventos adversos (EA) y anomalías de laboratorio y electrocardiograma (ECG)
- Concentraciones plasmáticas de octreótido en el tiempo

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 50 and Week 52

Semana 50 y semana 52

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

Yes

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

Bulgaria

Germany

Greece

Hungary

Italy

Netherlands

Poland

Russian Federation

Serbia

Spain

Sweden

Turkey

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

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

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:

124

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

140

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 will be switched back to standard treatment for acromegaly.

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

2020-02-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-09-23

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

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