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

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Brief Title

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

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

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Acromegaly

Intervention

Lanreotide Autogel®

Study Arms / Comparison Groups

 Lanreotide Autogel® 60mg, 90mg and 120mg
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

128

Start Date

October 2014

Completion Date

February 16, 2017

Primary Completion Date

November 2016

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%).

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02493517

Organization ID

8-55-52030-289

Secondary IDs

CTR20140698

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

January 2019