Acromegaly MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Product Name: OCTREOTIDE ACETATE
Product Code: C2L-OCT-01 PR , 10mg
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: OCTREOTIDE
CAS Number: 83150769
Concentration unit: mg
Sponsors
Mallinckrodt Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 35 days per injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: - 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;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. | — |
Countries
Hungary
Outcome results
None listed