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AcromegalyPhase 2POCNCT02111044

Phase II Study With ITF2984 in Acromegalic Patients

A Phase 2 study testing Octreotide, ITF2984 500 mcg and ITF2984 1000 mcg in people with Acromegaly, run by Italfarmaco at 26 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acromegaly
What is being tested?
Octreotide, ITF2984 500 mcg and ITF2984 1000 mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
26 sitesin 9 countries
Study dates
Apr 2014to Feb 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

26 sites in 9 countries.

26 sites in 9 countries

Italy7 sites

  • Presidio Ospedaliero di Montichiari

    Brescia

  • Policlinico G. Martino

    Messina

  • Fondazione Policlinico IRCCS

    Milan

  • IRCCS Ospedale San Raffaele

    Milan

  • Università Federico II

    Naples

  • Università di Pisa

    Pisa

  • San Giovanni Battista Molinette

    Torino

Other trials in Italy

Hungary4 sites

  • Az MH Honvédkórház

    Budapest

  • Semmelweis University

    Budapest

  • University of Pecs

    Pécs

  • University of Szeged

    Szeged

Other trials in Hungary

Poland3 sites

  • University Children's Hospital of Cracow

    Cracow

  • Klinika Endokrynologii Centrum Medycznego Kształcenia Podyplomowego

    Warsaw

  • Samodzielny Publiczny Szpital Kliniczny

    Wroclaw

Other trials in Poland

Romania3 sites

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

    Bucharest

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

    Bucharest

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

    Bucharest

Other trials in Romania

Czechia2 sites

  • St. Anne University Hospital

    Brno

  • University Hospital Hradec Kralove

    Hradec Králové

Other trials in Czechia

France2 sites

  • Université Hôpital Bicêtre

    Le Kremlin-Bicêtre

  • Hôpital de la TIMONE

    Marseille

Other trials in France

Netherlands2 sites

  • Leiden University Medical Center

    Leiden

  • Erasmus Medisch Centrum

    Rotterdam

Other trials in Netherlands

Serbia2 sites

  • Clinical Center of Serbia

    Belgrade

  • Clinical center of Nis

    Niš

Other trials in Serbia

Spain1 site

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela

Other trials in Spain

About this study

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

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.

Read the 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
Being tested
Octreotide, ITF2984 500 mcg, ITF2984 1000 mcg, ITF2984 2000 mcg
Keywords
de novo or partial responder to somatostatin analogues
Medical subject headings
Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OctreotideDrug

    Also called somatostatin analog

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

  • ITF2984 500 mcgDrug

    Also called somatostatin analog

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

  • ITF2984 1000 mcgDrug

    Also called somatostatin analog

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

  • ITF2984 2000 mcgDrug

    Also called somatostatin analog

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

Study groups in NCT02111044
Study groupRoleWhat they receive
OctreotideActive comparatorOctreotide 100 mcg sc three times daily (t.i.d) for 4 weeks
Receives: Drug: Octreotide
ITF2984 500 mcgExperimentalITF2984 500 mcg sc twice a day (b.i.d) for 4 weeks
Receives: Drug: ITF2984 500 mcg
ITF2984 1000 mcgExperimentalITF2984 1000 mcg sc b.i.d for 4 weeks
Receives: Drug: ITF2984 1000 mcg
ITF2984 2000 mcgExperimentalITF2984 2000 mcg sc b.i.d for 4 weeks
Receives: Drug: ITF2984 2000 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. effect of treatment on GH and IGF-1

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

    Measured: 4 weeks

Secondary outcomes (6)

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

    To investigate the biochemical response, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.

    Measured: 4 weeks

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

    To investigate the biochemical response, defined as a reduction of GH to no more than 2.5 mcg/l and/or normalization of IGF-1.

    Measured: 4 weeks

  3. signs and symptoms of acromegaly

    To evaluate variation of signs and symptoms of acromegaly at the end of each month of treatment in comparison with basal status.

    Measured: 4 weeks

  4. PK profile of ITF2984 and Octreotide

    To investigate the pharmacokinetic (PK) profile of ITF2984 and Octreotide

    Measured: 4 weeks

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

    To compare the effects on GH and IGF1 circulating levels of different doses of ITF2984

    Measured: 4 weeks

  6. effects of ITF2984 vs Octreotide on GH and IGF1 circulating levels

    To compare the effects on GH and IGF1 circulating levels of ITF2984 and Octreotide

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02111044
Sponsor's protocol ID
DSC/13/2984/05
Acronym
POC
Status last verified
Jun 2016
First submitted
8 Apr 2014
Last updated
16 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Octreotide, ITF2984 500 mcg and ITF2984 1000 mcg in people with Acromegaly, run by Italfarmaco at 26 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Italy, Hungary, Poland, Romania, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effect of treatment on GH and IGF-1 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02111044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.

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