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

NCT02493517 | Completed Phase 3 Results

• 2 other identifiers: 8-55-52030-289CTR20140698
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 10

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (8)

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

  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

  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

  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

  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

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

Study Arms (2)

Lanreotide Autogel® 60mg, 90mg and 120mg

EXPERIMENTAL

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).

Drug: Lanreotide Autogel®

Lanreotide 40mg PR (Lanreotide Acetate for Injection )

ACTIVE COMPARATOR

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.

Drug: Lanreotide Acetate

Interventions

Lanreotide Autogel® DRUG

Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate).

Lanreotide Autogel® 60mg, 90mg and 120mg

Lanreotide Acetate DRUG

Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection (provided as a sterile injectable lyophilisate of lanreotide acetate).

Lanreotide 40mg PR (Lanreotide Acetate for Injection )

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Ipsen: lead

Study Sites (10)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Fujian Provincial Hospital

Fuzhou, 350004, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, 510080, China

Location

Affiliate Hospital of Guiyang Medical College

Guizhou, 550004, China

Location

Jiangsu Provincial People's Hospital

Nanjing, 210029, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, 050000, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Tongji Medical College Huazhong University of Science & Technology

Wuhan, 430030, China

Location

Related Publications (1)

• 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.

  PMID: 32366244 DERIVED

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 9, 2015
• Study Start: October 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: February 16, 2017
• Last Updated: January 29, 2019
• Results First Posted: December 14, 2018

Record last verified: 2019-01

Locations

CN (10)