Acromegaly
Conditions
Interventions
Trade Name: Signifor
Product Name: Pasireotide LAR
Product Code: SOM230 LAR
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Sponsors
Erasmus Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A written informed consent. Male or female age = 18 years. The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-I levels. The patient is treated with lanreotide Autosolution or octreotide LAR for at least 6 months and has a serum IGF-I level above the 60th percentile and below 1.2 x ULN, 28 days after the last injection. 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 30
Exclusion criteria
Exclusion criteria: Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry. It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study. Has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure. Has been treated with any unlicensed drug within the last 30 days before study entry. Has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline phosphatase, or total bilirubin above 3 ULN). Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using contraception. Non-childbearing potential is defined as post-menopause for at least one year, surgical sterilization or hysterectomy at least three months before the start of the study. Has a history of, or known current, problems with alcohol or drug abuse. Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. Renal insufficiency, clearance 9.0%. Patients with a QTc > 500 ms on the EKG. Participation in a clinical trial in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to assess the percentage of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 24 weeks of treatment. ;Secondary Objective: To assess the percentage of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 48 weeks of treatment (V8). Also the number of patients and the necessary dose of PEG-V in patients with an IGF-I level within the age adjusted normal limits with pasireotide LAR (60 mg) combined with PEG-V, after 48 weeks of treatment (V8). Safety will be assessed based on: adverse events, clinical examination, vital signs, glucose tolerance, EKG, standard hematology, biochemistry, endocrine function tests, GH, PEG-V levels and liver function tests.;Primary end point(s): The main study endpoints are the proportion of patients who respond (defined as normalization of IGF-I levels within the age adjusted normal limits) after 24 weeks in the pasireotide LAR monotherapy group and the pasireotide LAR in combination with pegvisomant group. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the number of patients who remain within the IGF-I age adjusted normal limits with pasireotide LAR (60 mg) monotherapy, after 48 weeks of treatment (V8). Also the number of patients and the necessary dose of PEG-V in patients with an IGF-I level within the age adjusted normal limits with pasireotide LAR (60 mg) combined with PEG-V, after 48 weeks of treatment (V8). The proportion of patients who respond will be calculated along with the exact binomial two-sided 95% confidence interval in each treatment arm. The analysis will be based on the full analysis set. ;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
Netherlands
Contacts
Public ContactA. Muhammad MD PhD candidate
Erasmus Medical Centre Rotterdam
Outcome results
None listed