Phase II Study With ITF2984 in Acromegalic Patients

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Brief Title

Phase II Study With ITF2984 in Acromegalic Patients

Official Title

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

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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

effect of treatment on GH and IGF-1

Secondary Outcome

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

Condition

Acromegaly

Intervention

Octreotide

Study Arms / Comparison Groups

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

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

48

Start Date

April 2014

Completion Date

February 2016

Primary Completion Date

February 2016

Eligibility 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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Paolo Bettica, MD, , 

Location Countries

Czech Republic

Location Countries

Czech Republic

Administrative Informations


NCT ID

NCT02111044

Organization ID

DSC/13/2984/05


Responsible Party

Sponsor

Study Sponsor

Italfarmaco


Study Sponsor

Paolo Bettica, MD, Study Director, Italfarmaco


Verification Date

June 2016