Phase II Study With ITF2984 in Acromegalic Patients

NCT02111044 | Completed Phase 2

• 1 other identifier: DSC/13/2984/05
• Study Type: interventional
• Target: 48
• Locations: 9 countries
• Sites: 26

Brief 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.

Conditions

Acromegaly

Keywords

de novo or partial responder to somatostatin analogues

Outcome Measures

Primary Outcomes (1)

• effect of treatment on GH and IGF-1

  To investigate the effect of treatment on GH and IGF-1 concentrations

  4 weeks

Secondary Outcomes (6)

• reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1

  4 weeks

• reduction of GH to no more than 2.5 mcg/l and/or normalization of IGF-1

  4 weeks

• signs and symptoms of acromegaly

  4 weeks

• PK profile of ITF2984 and Octreotide

  4 weeks

• dose-response effect of ITF2984 on GH and IGF1 circulating levels

  4 weeks

Study Arms (4)

Octreotide

ACTIVE COMPARATOR

Octreotide 100 mcg sc three times daily (t.i.d) for 4 weeks

Drug: Octreotide

ITF2984 500 mcg

EXPERIMENTAL

ITF2984 500 mcg sc twice a day (b.i.d) for 4 weeks

Drug: ITF2984 500 mcg

ITF2984 1000 mcg

EXPERIMENTAL

ITF2984 1000 mcg sc b.i.d for 4 weeks

Drug: ITF2984 1000 mcg

ITF2984 2000 mcg

EXPERIMENTAL

ITF2984 2000 mcg sc b.i.d for 4 weeks

Drug: ITF2984 2000 mcg

Interventions

Octreotide DRUG

octreotide 100 mcg sc t.i.d. for 4 weeks

Also known as: somatostatin analog

Octreotide

ITF2984 500 mcg DRUG

ITF2984 500 mcg sc b.i.d for 4 weeks

Also known as: somatostatin analog

ITF2984 500 mcg

ITF2984 1000 mcg DRUG

ITF2984 1000 mcg sc b.i.d for 4 weeks

Also known as: somatostatin analog

ITF2984 1000 mcg

ITF2984 2000 mcg DRUG

ITF2984 2000 mcg sc b.i.d for 4 weeks

Also known as: somatostatin analog

ITF2984 2000 mcg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Patients with active acromegaly due to a pituitary adenoma. Active acromegaly should be confirmed by 2h five point mean GH level higher than 5 mcg/liter, lack of suppression of GH nadir to less than 1 mcg/liter after oral glucose tolerance test, and elevated IGF-1 for age and sex-matched controls.
• Patients aged between 18 to 80 years old inclusive.
• Patients treated with previous surgery and/or medical therapy or previously untreated (de novo). 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 and 2 weeks for octreotide sc must be foreseen. Partial responder means a significant decrease (\>50%), without achievement of control of GH and/or IGF-1 levels and/or \>20 % tumor shrinkage after at least 6 months of SRL therapy.
• Patients with GH level and IGF-1 level for age and sex-matched controls out of range at baseline (GH at baseline \> 2.5mcg/l).

You may not qualify if:

• Patients undergone pituitary surgery within the prior 6 months.
• Patients who have received pituitary radiotherapy (within last 10 years).
• Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
• Patients with compression of the optic chiasm causing any visual field defect.
• Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression.
• Patients with uncontrolled diabetes defined as having a fasting glucose \> 150 mg/dL (8.3 mmol/L) or HbA1c ≥ 8% (Patients can be rescreened after diabetes is brought under adequate control).
• A marked baseline prolongation of QT/QTc interval i.e. a mean QT/QTc \>450ms after 3 consecutive measurements at least 5 minutes apart.
• Patients with abnormal coaugulation, Prothrombin time (PT), activated partial thromboplastin time (PTT) elevated by 30% above normal limits.
• Symptomatic cholelithiasis, gallstone or chronic liver disease.
• Patients who have a history or presence at the moment of the screening visit of pancreatitis.
• Clinically significant GI, renal or hepatic disease (in the opinion of investigator).
• AST and/or ALT\>2ULN.
• Severely reduced renal function (serum creatinine \>2.0 mg/dl or 176µmol/L)
• Active HBV and/or active HCV infection.
• Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit.

Sponsors & Collaborators

• Italfarmaco: lead

Study Sites (26)

St. Anne University Hospital

Brno, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, Czechia

Location

Université Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

Hôpital de la TIMONE

Marseille, France

Location

Az MH Honvédkórház

Budapest, Hungary

Location

Semmelweis University

Budapest, Hungary

Location

University of Pecs

Pécs, Hungary

Location

University of Szeged

Szeged, Hungary

Location

Presidio Ospedaliero di Montichiari

Brescia, Italy

Location

Policlinico G. Martino

Messina, Italy

Location

Fondazione Policlinico IRCCS

Milan, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Università Federico II

Napoli, Italy

Location

Università di Pisa

Pisa, Italy

Location

San Giovanni Battista Molinette

Torino, Italy

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

University Children's Hospital of Cracow

Krakow, Poland

Location

Klinika Endokrynologii Centrum Medycznego Kształcenia Podyplomowego

Warsaw, Poland

Location

Samodzielny Publiczny Szpital Kliniczny

Wroclaw, Poland

Location

Institutul de Endocrinologie C.I.Parhon, Sectia clinica de endocrinologie II

Bucharest, Romania

Location

Institutul de Endocrinologie C.I.Parhon, Sectia clinica de endocrinologie I

Bucharest, Romania

Location

Institutul de Endocrinologie C.I.Parhon, Sectia clinica de endocrinologie VI

Bucharest, Romania

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

Clinical center of Nis

Niš, Serbia

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

MeSH Terms

Conditions

Acromegaly

Interventions

Octreotide; Somatostatin

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

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Paolo Bettica, MD

  Italfarmaco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-06

Locations

ES (1); SE (2); NL (2); PL (3); FR (2); IT (7); CZ (2); HU (4); RO (3)