Phase II Study With ITF2984 in Acromegalic Patients

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italfarmaco
• Treatments: Octreotide; Somatostatin

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

• Patients who have had a significant cardiovascular disease in the three months prior to inclusion such as congestive heart failure (NYHA [New York Heart Association] class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, sustained clinically significant bradycardia, advanced heart block, or with a history of acute myocardial infarction.

• 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.

• Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or steroid hormone replacement therapy for at least the previous 3 months.

• Known hypersensitivity to any of the study medications, or components thereof or a history of drug or other allergy that in the opinion of the Investigator contraindicates their participation.

• Female patients who are pregnant or lactating, and female patient who are of childbearing potential or male patient with female partners of childbearing potential who do not accept the contraception requirements reported in the protocol.

• Patients who have participated in any clinical investigation with an Investigational drug within 3 months before study entry.

• Current or recent (< 2 months) therapy with pegvisomant or cabergoline.