The effect of lanreotide on non-functioning pituitary macroadenoma size

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 - GALANT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001234-22-NL

Enrollment

Registered

2015-07-02

Start date

2015-07-01

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinically non-functioning pituitary macroadenoma MedDRA version: 20.0 Level: PT Classification code 10029556 Term: Non-secretory adenoma of pituitary System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Somatuline autosolution Pharmaceutical Form: Solution for injection in pre-filled syringe Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • NFMA with suprasellar extension (in previously operated patients: residual adenoma or recurrence > 10 mm) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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.;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);Timepoint(s) of evaluation of this end point: MRI: baseline, 6 months/week 24 and at end of study after 18 months/week 72	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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.;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);Timepoint(s) of evaluation of this end point: MRI: baseline, 6 months/week 24 and at end of study after 18 months/week 72

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Secondary

Measure	Time frame
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;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)	—

Measure

Time frame

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;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)

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Countries

Netherlands

Contacts

Public ContactEric Fliers, principal investigator

Academic Medical Center

e.fliers@amc.uva.nl0031205666071

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026