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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly

Short name LANTERN

NCTNCT02493517 (opens ClinicalTrials.gov in a new tab)Other id8-55-52030-289Other idCTR20140698
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
128 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Oct 2014
Primary completion
Nov 2016
Completion
16 Feb 2017
First posted
9 Jul 2015 (estimated)
Last update posted
29 Jan 2019
Conditions
Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. Ph 3

    LANTERN

    NCT02493517

    Oct 2014 to 16 Feb 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.

Interventions

  • Lanreotide Autogel®Drug
  • Lanreotide AcetateDrug

Arms2

  • Experimental

    Lanreotide Autogel® 60mg, 90mg and 120mg

    Lanreotide Autogel 90mg from day 1 to week 13, 1 injection every 4 weeks (4 in total), titrated to 60mg, 90mg, or 120mg at week 17, then from week 17 to week 29 each group receives 1 injection every 4 weeks (4 in total/group).

  • Active comparator

    Lanreotide 40mg PR (Lanreotide Acetate for Injection )

    Lanreotide PR 40mg from day 1 to week 15, 1 injection every 10 days, then at dose titration (week 16) injection frequency will either remain at 10 days or increase to 14 days or decrease to 7 days up until week 30 or 31.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit

    Time frame · Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The standardised mean change from Baseline in age-adjusted log-transformed IGF-1 standard deviation score (SDS) at EOST/EW is presented for subjects treated with both lanreotide Autogel and lanreotide PR. Back-transformed results are presented in addition to the results without back-transformation. For each subject the IGF-1 SDS value was calculated based on the z-score derivation: IGF-1 SDS = (IGF-1 - mean)/ standard deviation (SD), with mean and SD derived from the upper limit of normal (ULN) and lower limit of normal (LLN) margins for each age category. ULN = Mean + 2 SD; LLN = Mean - 2 SD. The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A negative change in the SDS indicates a decrease in the mean age-adjusted IGF-1 values.

Secondary outcomes(8)

  1. Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit

    Time frame · Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The percentage of subjects with normal age-adjusted IGF-1 levels at the EOST/EW Visit is presented for subjects treated with Lanreotide Autogel and Lanreotide PR. At baseline, all subjects had abnormal IGF-1 levels as per protocol entry criteria.

  2. Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit

    Time frame · Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The percentage of subjects with GH ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels \>2.5 mcg/L as per protocol entry criteria.

  3. The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit

    Time frame · Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The percentage of subjects with GH ≤1 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels \>2.5 mcg/L as per protocol entry criteria.

  4. Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit

    Time frame · Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The percentage of subjects with normal age-adjusted IGF-1 levels and who have GH levels \>1 mcg/L but ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. The calculation of percentages was based on the overall ITT population. At baseline, all subjects had abnormal IGF-1 levels and GH levels \>2.5 mcg/L as per protocol entry criteria.

  5. Mean Change From Baseline in GH Values at the EOST/EW Visit

    Time frame · Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The mean change from baseline in GH values at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR.

  6. Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline

    Time frame · Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The percentage of subjects with at least a 20% reduction in the solid component of the tumour volume at the EOST/EW Visit compared to baseline is presented for the subgroup of subjects who had solid tumours at baseline. The tumour volume was measured by Magnetic Resonance Imaging (MRI) at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers.

  7. Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit

    Time frame · Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The median percentage change in the solid component of the tumour volume from baseline to the EOST/EW Visit is presented. The tumour volume was measured by MRI at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers.

  8. Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline

    Time frame · Baseline, Week 13 Visit and EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

    Registry description

    The percentage of subjects with at least one symptom of acromegaly at Week 13 and at the EOST/EW Visit compared with baseline is presented for subjects treated with lanreotide Autogel and lanreotide PR. The symptoms of acromegaly monitored included: headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit

GroupValue (SDS)Spread
Lanreotide Autogel-0.840.15
Lanreotide PR-0.520.17
Secondary and other outcome results(7)
Secondary outcomeNumber· Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit

GroupValue (Percentage of Subjects)
Lanreotide Autogel15.6
Lanreotide PR9.4
Secondary outcomeNumber· Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit

GroupValue (Percentage of Subjects)
Lanreotide Autogel29.7
Lanreotide PR31.3
Secondary outcomeNumber· Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit

GroupValue (Percentage of Subjects)
Lanreotide Autogel10.9
Lanreotide PR9.4
Secondary outcomeNumber· Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit

GroupValue (Percentage of Subjects)
Lanreotide Autogel7.8
Lanreotide PR3.1
Secondary outcomeMean· Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

Mean Change From Baseline in GH Values at the EOST/EW Visit

GroupValue (mcg/L)Spread
Lanreotide Autogel-9.54822.852
Lanreotide PR-13.18220.224
Secondary outcomeNumber· Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline

GroupValue (Percentage of Subjects)
Lanreotide Autogel45.5
Lanreotide PR50.9
Secondary outcomeMedian· Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).

Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit

GroupValue (Percentage change in tumour volume)
Lanreotide Autogel-17.870
Lanreotide PR-20.120

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Lanreotide AutogelSubjects were randomised to receive lanreotide Autogel. Lanreotide Autogel was administered s.c. at a fixed dose of 90 mg every 4 weeks from Day 1, Week 1 to Week 17. At Week 17 the dose was continued at 90 mg or titrated to 60 mg or 120 mg every 4 weeks according to the individual subject's response as determined by the mean value of the GH cycles and IGF-1 measured at the previous Week 13 Visit. The last dose of lanreotide Autogel was given at Week 29, followed by EOST/EW Visit at Week 33.0 / 641 / 6459 / 64
Lanreotide PRSubjects were randomised to receive lanreotide PR. Lanreotide PR was administered i.m. every 10 days from Day 1, Week 1 up to Week 16. At Week 16 the injection interval was maintained at 10 days or was adjusted to 7 or 14 days according to the individual subject's response as determined by the mean value of GH cycle and IGF-1 measured at the previous visit at Week 13. The last dose of lanreotide PR was administered at Week 31. The EOST/EW Visit was at Week 32.0 / 642 / 6462 / 64

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2020

7 results

Efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release in Chinese patients with active acromegaly: results from a phase 3, prospective, randomized, and open-label study (LANTERN).

An et al. 2020BMC endocrine disorderscited by 1

PMID 32366244PMC7199333DOI 10.1186/s12902-020-0524-7PUB-32366244

CC BY7 results
Download PDFSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subject has active acromegaly defined as elevated GH and IGF-1 levels (measured at a central laboratory) as outlined below: * A serum level for IGF-1 ≥1.3 x upper limit of normal range (ULN) during the screening period (applicable to both treatment naïve subjects and subjects who have stopped treatment and undergone a washout period prior to Visit 1(Week -4). * Subjects must have mean serum GH concentration ≥2.5 μg/L in a GH cycle (5 samples taken at 0, 30, 60, 90 and 120 minutes) during the screening period. * The subject has undergone surgical removal of an adenoma for acromegaly at least 3 months prior to Screening, or is likely to require pituitary surgery in the future but not before completing at least 32 weeks of study treatment plus an additional follow up of 8 weeks for subjects taking part in the pharmacokinetics (PK) extension, or for whom pituitary surgery is not an option (due to contraindications, refusal etc.) and is therefore never likely to undergo pituitary surgery. Exclusion Criteria: * The subject has been treated with radiotherapy within 10 years prior to Screening. * The subject has been treated with lanreotide Autogel, lanreotide PR, pegvisomant, cabergoline or octreotide LAR within 3 months of Screening or octreotide immediate release (IR) or bromocriptin within 2 weeks of Screening. * The subject has a history of or currently presents with clinically significant ventricular or atrial dysrhythmias ≥Grade 2, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. * The subject has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) \>8.5%).

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