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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lanreotide Autogel®
Lanreotide Acetate
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

  • Peking Union Medical College Hospital
  • West China Hospital, Sichuan University
  • Fujian Provincial Hospital
  • The First Affiliated Hospital, Sun Yat-sen University
  • Affiliate Hospital of Guiyang Medical College
  • Jiangsu Provincial People's Hospital
  • Huashan Hospital Fudan University
  • The Second Hospital of Hebei Medical University
  • Tianjin Medical University General Hospital
  • Tongji Medical College Huazhong University of Science & Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lanreotide Autogel® 60mg, 90mg and 120mg

Lanreotide 40mg PR (Lanreotide Acetate for Injection )

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit
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.
Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit
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.
The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit
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.
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
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.
Mean Change From Baseline in GH Values at the EOST/EW Visit
The mean change from baseline in GH values at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR.
Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline
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.
Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit
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.
Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline
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.

Full Information

First Posted
July 7, 2015
Last Updated
January 25, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT02493517
Brief Title
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
Acronym
LANTERN
Official Title
A Phase III, Prospective, Randomised, Open Label Study to Compare the Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg PR in Subjects With Active Acromegaly
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanreotide Autogel® 60mg, 90mg and 120mg
Arm Type
Experimental
Arm Description
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).
Arm Title
Lanreotide 40mg PR (Lanreotide Acetate for Injection )
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lanreotide Autogel®
Intervention Description
Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate).
Intervention Type
Drug
Intervention Name(s)
Lanreotide Acetate
Intervention Description
Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection (provided as a sterile injectable lyophilisate of lanreotide acetate).
Primary Outcome Measure Information:
Title
Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit
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.
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).
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit
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.
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).
Title
Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit
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.
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).
Title
The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit
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.
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).
Title
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
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.
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).
Title
Mean Change From Baseline in GH Values at the EOST/EW Visit
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.
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).
Title
Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline
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.
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).
Title
Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit
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.
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).
Title
Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Fujian Provincial Hospital
City
Fuzhou
ZIP/Postal Code
350004
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Affiliate Hospital of Guiyang Medical College
City
Guizhou
ZIP/Postal Code
550004
Country
China
Facility Name
Jiangsu Provincial People's Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Huashan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tongji Medical College Huazhong University of Science & Technology
City
Wuhan
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32366244
Citation
An Z, Lei T, Duan L, Hu P, Gou Z, Zhang L, Durand-Gasselin L, Wang N, Wang Y, Gu F; LANTERN study investigators. 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). BMC Endocr Disord. 2020 May 4;20(1):57. doi: 10.1186/s12902-020-0524-7.
Results Reference
derived

Learn more about this trial

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

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