Clinical Trials Register

Summary
EudraCT Number:	2015-001234-22
Sponsor's Protocol Code Number:	NL52821.018.15
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-07-02
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

Netherlands - Competent Authority

A.2

EudraCT number

2015-001234-22

A.3

Full title of the trial

A randomized placebo-controlled study in patients with a Gallium-68 DOTATATE PET/CT positive, clinically non-functioning pituitary macroadenoma (NFMA) of the effect of Lanreotide autosolution on Tumor (adenoma) size

Een gerandomiseerde, placebo-gecontroleerde studie onder patiënten met Gallium-68 DOTATATE PET/CT positieve, klinisch niet-functionerende hypofyse macroadenomen (NFMA) naar het effect van Lanreotide autosolution op Tumor(adenoom)grootte

A.3.1

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

The effect of lanreotide on non-functioning pituitary macroadenoma size

Het effect van lanreotide op de grootte van niet-functionerende hypofyse macroadenomen

A.3.2

Name or abbreviated title of the trial where available

GALANT

A.4.1

Sponsor's protocol code number

NL52821.018.15

A.5.4

Other Identifiers

Name:

Nederlands Trial Register

Number:

NTR5275

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	Academic Medical Center
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ipsen Farmaceutica
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Academic Medical Center
B.5.2	Functional name of contact point	Eric Fliers, principal investigator
B.5.3	Address:
B.5.3.1	Street Address	Meibergdreef 9
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1100 AZ
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031205666071
B.5.5	Fax number	0031206917682
B.5.6	E-mail	e.fliers@amc.uva.nl

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	Somatuline autosolution
D.2.1.1.2	Name of the Marketing Authorisation holder	Ipsen Farmaceutica
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Solution 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.3.11 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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Clinically non-functioning pituitary macroadenoma

E.1.1.1

Medical condition in easily understood language

Pituitary adenoma (tumor)

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	10029556
E.1.2	Term	Non-secretory adenoma of pituitary
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 investigate the efficacy of lanreotide autosolution during 18 months, as compared to placebo, to reduce and/or stabilize adenoma size in patients with NFMA and positive pituitary somatostatin receptor imaging using Gallium-68 DOTATATE PET/CT.

E.2.2

Secondary objectives of the trial

1. To assess the safety of lanreotide use in NFMA based on the number of (serious) adverse events.
2. To compare the change in quality of life between the lanreotide autosolution 120 mg and placebo group.
3. To compare the change in NFMA volume over 18 months between the lanreotide autosolution 120 mg and placebo group.
4. To compare time to tumor progression (i.e. tumor growth) between the lanreotide autosolution 120 mg and placebo group.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• NFMA with suprasellar extension (in previously operated patients: residual adenoma or recurrence > 10 mm)

E.4

Principal exclusion criteria

• Hypersensitivity for somatostatin or similar peptides
• Optic chiasm compression with visual field defects (this is an operation indication)
• Obstructive neuroendocrine gut tumor
• Previous radiation therapy in the pituitary region
• Symptomatic and proven cholelithiasis
• Use of dopamine agonists in the past 6 months
• Use of somatostatin analogues in the past 6 months
• Pregnancy (plans)
• Any contraindication to perform MRI with gadolinium-based contrast agent

E.5 End points

E.5.1

Primary end point(s)

The change in cranio-caudal NFMA size over 18 months of lanreotide or placebo as measured on MRI (expressed in millimetes)

E.5.1.1

Timepoint(s) of evaluation of this end point

MRI: baseline, 6 months/week 24 and at end of study after 18 months/week 72

E.5.2

Secondary end point(s)

1. Number of adverse effects
2. Change in quality of life
3. Change in NFMA volume over 18 months as measured with 3DT1 MRI
4. Time to tumor progression (i.e. tumor growth)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Adverse events can be reported throughout the study and will be specifically asked about at the visits at week 24, week 48 and week 72 (end of study)
2. Baseline, week 24, week 48, week 72 (end of study)
3. Same as primary endpoint: baseline, 6 months/week 24 and at end of study after 18 months/week 72
4. Throughout the study including the predefined time points where MRI is performed

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

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

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

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

LVLS, the trial ends when the last subject has completed the last visit and pituitary MRI

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

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.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)

After the study is finished patients will continue with their regular follow-up appointments and examinations as before the trial. If the trial has a favourable outcome (i.e. smaller tumour size in Lanreotide users) discussion will follow if Somatuline autosolution can be registered for use in Gallium-68 DOTATATE PET-positive non-functioning pituitary macroadenoma.

Na het einde van de studie zullen de patiënten hun reguliere behandeling hervatten in de vorm van controle afspraken en onderzoeken zoals vóór de studie. Indien de resultaten positief blijken (oftewel: afname van tumorgrootte in lanreotide gebruikers) dan zal bekeken worden of Somatuline autosolution geregistreerd kan worden voor de behandeling van Gallium-68 DOTATATE PET-positieve niet-functionerende hypofyse macroadenomen.

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

2015-07-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-05-26

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