NCT02111044

Phase II Study With ITF2984 in Acromegalic Patients

A Randomized, Multicenter, Phase II Study to Investigate Efficacy and Safety of ITF2984 in Acromegalic Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate in acromegalic patients the effect of different doses of ITF2984 on GH and IGF-1 concentrations and to investigate safety and tolerability of three different doses of ITF2984.

Detailed description

The study will enroll patients with active acromegaly, de novo or partial responder to previous treatment with somatostatin analogues. For patients who had previously received medical therapy for acromegaly a washout periods before study entry of 3 months for long-acting formulation of somatostatin analogs, 2 weeks for octreotide sc, 2 months for pegvisomant and/or cabergoline must be foreseen. Each patient will be randomized and wll remain in the study for about 6 months, and they will attend a visit every two weeks. The patients will be treated for 4 months in a total, in particular every month of treatment will be followed by a washout period of 2 weeks. At each month of treatment the patients will receive one of the four treatment as reported below: Octreotide 100 mcg sc three times daily (t.i.d) for 4 weeks, ITF2984 500 mcg sc twice a day (b.i.d) for 4 weeks, ITF2984 1000 mcg sc b.i.d for 4 weeks, ITF2984 2000 mcg sc b.i.d for 4 weeks. Patients will be randomized using a 4 way crossover design to receive ITF2984 or octreotide at each treatment month. Each patient will receive all of the four treatments overseen in this study.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Octreotide	octreotide 100 mcg sc t.i.d. for 4 weeks
DRUG	ITF2984 500 mcg	ITF2984 500 mcg sc b.i.d for 4 weeks
DRUG	ITF2984 1000 mcg	ITF2984 1000 mcg sc b.i.d for 4 weeks
DRUG	ITF2984 2000 mcg	ITF2984 2000 mcg sc b.i.d for 4 weeks

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-04-10
• Last updated: 2016-06-16

Locations

26 sites across 9 countries: Czechia, France, Hungary, Italy, Netherlands, Poland, Romania, Serbia, Spain