Acromegalia

• Register: EUCTR
• Last refreshed on: 23 May 2016
• Main ID: EUCTR2013-003183-31-FR
• Date of registration: 22/06/2015
• Prospective Registration: No
• Primary sponsor: ITALFARMACO S.p.A.
• Public title: Acromegalia
• Scientific title: A Randomized, Multicenter, Phase II study to Investigate Efficacy and Safety of ITF2984 in Acromegalic patients.
• Date of first enrolment: 28/11/2014
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003183-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, France, Hungary, Italy, Netherlands, Poland, Romania, Spain

Contacts

• Name: Clinical Scientist
• Affiliation: ITALFARMACO S.p.A.

• Name: Clinical Scientist
• Affiliation: ITALFARMACO S.p.A.

Key inclusion & exclusion 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
- Patients undergone pituitary surgery within the prior 6 months.
- Patients who have received pituitary radiotherapy (within last 10 years).
- 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 with significant cardiovascular morbidity within the three months preceding enrollment.
- Symptomatic cholelithiasis, gallstone or chronic liver disease.
- Clinically significant GI, renal or hepatic disease (in the opinion of investigator).
- AST and/or ALT>2ULN.
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acromegaly

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Product Name: ITF2984 diacetate
Product Code: ITF2984
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: NA
Other descriptive name: ITF2984
Concentration unit: µg microgram(s)
Concentration type: range
Concentration number: 500-2000

Trade Name: Octreotide
Product Name: OCTREOTIDE
Pharmaceutical Form: Solution for injection in pre-filled syringe

Primary Outcome(s)

Primary end point(s): - Change of GH and/or IGF-1 levels at the end of each month of treatment.

Timepoint(s) of evaluation of this end point: At the end of each month of treatment

Secondary Objective: - To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.
- To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l and/or normalization of IGF-1.
- To evaluate variation of signs and symptoms of acromegaly at the end of each month of treatment in comparison with basal status.
- To investigate the pharmacokinetic (PK) profile of ITF2984 and Octreotide
- To compare the effects on GH and IGF1 circulating levels of different doses of ITF2984
- To compare the effects on GH and IGF1 circulating levels of ITF2984 and Octreotide

Main Objective: To investigate the effect of treatment on GH and IGF-1 concentrations.

Secondary Outcome(s)

Secondary end point(s): - Number and percentage of patients with reduction of GH < 1.0 mcg/l and/or normalization of IGF-1 at the end of each month of treatment.
- Number and percentage of patients with reduction in GH <2.5 mcg/l and/or normalization of IGF-1 at the end of each month of treatment.
- Number and percentage of patients with improvement of signs and symptoms of acromegaly at the end of each month of treatment.

Timepoint(s) of evaluation of this end point: At the end of each month of treatment

Secondary ID(s)

2013-003183-31-CZ

DSC/13/2984/05

Source(s) of Monetary Support

ITALFARMACO S.p.A.