Acromegaly MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Product Name: Octreotide Implant
Pharmaceutical Form: Implant
INN or Proposed INN: OCTREOTIDE ACETATE
CAS Number: 79517-01-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Endo Pharmaceuticals Solutions Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female with acromegaly 2. Age = 18 years and = 80 years 3. Confirmed diagnosis of a growth hormone-secreting tumor based on historical data and meeting at least one of the following criteria (a or b): a. Patients in whom an oral glucose tolerance test (OGTT) was performed and meeting all of the following (based on previous historical data): i. GH = 1.0 ng/mL during the OGTT and ii. IGF-1 level = 20% above the upper limit of age-and sex-adjusted normal value during the OGTT and iii. Pituitary tumor demonstrable on MRI b. Patients in whom an OGTT was not performed and meeting all of the following (based on previous historical data): i. IGF-1 level = 20% above the upper limit of age-and sex-adjusted normal value and ii. Confirmation of a growth hormone-secreting tumor on pathologic examination of tissue removed at surgery and iii. Pituitary tumor demonstrable on MRI 4. No pituitary tumor present or has tumor present that is = 3 mm in distance from the optic chiasm 5. Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to Screening 6. Must show a response to octreotide treatment with documented laboratory results at the Screening visits (mean of Day -60 and Day -30 results) defined as follows: a. IGF-1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, lactating, or of child-bearing potential who are not practicing a medically acceptable method of birth control 2. Pituitary surgery less than 3 months prior to Screening 3. Liver disease (e.g., cirrhosis, chronic active or persistent hepatitis or persistent abnormalities of ALT, AST (level > 2X normal), alkaline phosphatase (level > 2X normal), or direct bilirubin (level > 1.5X normal)) 4. Other laboratory values considered by the Investigator or Sponsor to be clinically significant 5. Unstable angina, sustained ventricular arrhythmias or heart failure (NYHA III and IV) 6. Acute myocardial infarction within 3 months of Screening 7. Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c = 9 % 8. Symptomatic cholelithiasis 9. History of drug or alcohol abuse within 6 months of Screening 10. Received any investigational drug or participated in another clinical trial within 30 days of Screening 11. Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before the start of Screening 12. Received pegvisomant, lanreotide or a dopamine agonist within 3 months of Screening, or at any time during the trial 13. Received a previous octreotide implant 14. History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, any other severe coexisting or terminal systemic disease that limits life expectancy or may interfere with the conduct of the study, or patients who are incarcerated in penal institutions or are committed to mental institutions 15. Candidate on a waiting list for surgery while on study 16. Patient who, through completion of the study, would have donated in excess of: a. 500 mL of blood in 42 days; b. 1500 mL of blood in 180 days; or c. 2500 mL of blood in 1 year 17. Received new or non-stable dose of hormone replacement therapy within 3 months of Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the octreotide implant during 24 weeks of treatment in patients with acromegaly who had been previously treated with octreotide depot; ;Secondary Objective: Secondary objectives include the assessment of the effects of treatment with the implant over 24 weeks on: • Signs and symptoms scores • Quality of Life score • Pituitary tumor size • Patients Treatment Assessment (a patient-reported assessment of the treatment) ;Primary end point(s): • Primary efficacy will be assessed via measurement of the pharmacodynamics resulting from treatment with the implant, ie, growth hormone (GH) and insulin-like growth factor (IGF-1) concentration levels. The primary endpoints will be the average concentrations of GH and IGF-1 levels over the 24-week treatment period. • Safety and tolerability resulting from treatment with the implant for 24 weeks will be evaluated on the basis of spontaneously-reported adverse events and changes in physical examinations, vital signs, 12-lead ECG, clinical laboratory data, concomitant medications, pituitary tumor size, and gall bladder ultrasonography outcomes. | — |
Countries
Czech Republic, Hungary, Poland, Spain
Outcome results
None listed