E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000599 |
E.1.2 | Term | Acromegaly |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR administered intra muscularly every 6 weeks in acromegalic patients |
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E.2.2 | Secondary objectives of the trial |
- To determine the percentage of patients with controlled mean GH and normal (gender and age matched values) IGF-1 serum concentrations following the injection of C2L-OCT-01 PR, every 6 weeks. - To measure the octreotide plasma concentrations following several injections (pre and 2 hours post injection). - To assess the acromegaly severity score index and patient's health status. - To evaluate pituitary tumor size during C2L-OCT-01 PR treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age of 18 years and above, • Diagnosis of active acromegaly based on the following criteria: o Typical clinical features, o Failure of GH to suppress below 1 ng/mL during an oral glucose tolerance test (OGTT), and o Elevated serum IGF-1 levels above gender- and age- matched values. (i.e. “normal values”) • The following patients will be eligible: o Patients presently treated with Sandostatin LAR® 10 mg or 20 mg for a minimum 12 weeks and having normal IGF-1 values. o Patients not currently treated with somatostatin analogues and having elevated IGF-1 values. These patients could be naïve to somatostatin analogues or have stopped their treatment with somatostatin analogues. o Patients naïve to somatostatin analogues must have demonstrated tolerance to a seven day treatment with 50 µg Sandostatin® immediate release s.c administered three times a day. o If patients were previously treated with somatostatin analogue prolonged release formulation, last injection should be more than 56 days prior to the screening visit. • All women of reproductive age must have a negative pregnancy test prior to start of study medication. • Having the ability to understand the requirements of the study, provide written informed consent to participate in this study and agree to abide by the study restrictions.
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E.4 | Principal exclusion criteria |
• Female patients of childbearing potential age who are not using adequate contraception. (i.e. oral or trans-dermal contraceptive drugs, intra-uterine device, diaphragm) • Pregnant or lactating female patients. • Treated with a GH receptor antagonist (pegvisomant) within 12 weeks prior to admission into the study. • Have undergone pituitary surgery less than 12 weeks prior to admission into the study. • Have undergone radiotherapy within two years prior to admission into the study. • Presents any contraindication (hypersensitivity to octreotide formulation) or non responder to Sandostatin-LAR® treatment. • Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or patients with persistent ALT, AST> 2 X ULN, serum creatinine >2 X ULN, serum bilirubin >2 X ULN. • Have other conditions that could result in altered GH or IGF-1 levels (such as anorexia nervosa, Laron’s syndrome, treatment with levodopa or narcotics analgesics, heroin abuse, etc.) • Patients with Diabetes type I (insulin-dependent) or with uncontrolled Diabetes type II as indicated by the presence of ketoacidosis or HbA1C 10%. • Presents clinically significant signs and symptoms potentially related to a tumor compression of the optical chiasm, based on judgment of the investigator. • Patients with symptomatic cholelithiasis. • Have received an investigational drug or participated in a clinical trial within 30 days of study entry. • Presents clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy. • Patients who have used a dopamine agonist less than 30 days prior to study entry. • Patients requiring Sandostatin-LAR® to be dosed every < 21 or > 35 days per injection.
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the safety profile.
The primary safety endpoints are: • Incidence/severity of treatment-emergent adverse events. • Serial vital signs (blood pressure, heart rate) and ECG monitoring. • Echocardiography and gallbladder ultrasound evaluations. • Serial physical examinations. • Serial laboratory evaluations including fasting glucose.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |