Laurence Katznelson
PHASE III, OPEN-LABEL, MULTICENTER INTERNATIONAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN OCTREOTIDE IMPLANT VERSUS SANDOSTATIN LAR? DEPOT IN PATIENTS WITH ACROMEGALY
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study is designed to include two active phases. In the Primary Treatment Phase you will be randomized (assigned by chance to different treatment groups) to receive either Octreotide Implant for 6 months or S-LAR? injections given every 4 weeks for 6 months. The chance to receive Octreotide Implant is 3 out of 4. In other words 75 % of the subjects will receive Octreotide Implant. If you are eligible to participate in the Extension Phase and wish to take part, there are two options for you at week 24 visit: ? If you had received the implant, it will be removed and a new one is to be implanted for 6 more months or; ? If you received S-LAR?, this treatment will be stopped and an Octreotide Implant will be inserted in the loose skin above your elbow (the inner area of the upper arm). You will have this implant for 6 more months.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Octreotide Implant
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to 80 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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 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 < 20% above the normal age and sex-adjusted levels and GH < 5.0 ng/mL
7. Without, in the opinion of the investigator; clinically significant findings on physical exam, laboratory values, and vital signs; or unstable chronic medical conditions
8. Be able to communicate, complete questionnaires independently, provide and sign written informed consent, and willing to participate and comply with study requirements.
Key Exclusion Criteria:
1. Women who are pregnant, lactating, or of child-bearing potential who are not practicing a medically acceptable method of birth control listed below:
? For females of childbearing potential, negative serum pregnancy test prior to enrollment, not breastfeeding for study duration, and willingness to use accepted forms of reliable birth control for study duration [including bilateral tubal ligation, use of oral contraceptives, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera?, hormonal implants, partner vasectomy, and total abstinence]. Pregnancy tests are not required (indicate ?n/a?) for males, or for females not of childbearing potential (post-menopausal with last menstrual period >1 year ago or total hysterectomy with bilateral oophorectomy)
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
Any waiver of these inclusion and exclusion criteria must be approved by the Investigator and the Sponsor on a case-by-case basis prior to enrolling the patient. The waiver must be documented by the Investigator and the Sponsor. No patient will be allowed to enroll in this study more than once.
Additional Study Details
Official Title:
PHASE III, OPEN-LABEL, MULTICENTER INTERNATIONAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN OCTREOTIDE IMPLANT VERSUS SANDOSTATIN LAR? DEPOT IN PATIENTS WITH ACROMEGALYAnticipated start date:
9/16/2009Lead Sponsor:
Endo Pharmaceuticals, Inc.Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
Assignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- The primary endpoints will be the average concentrations of GH and IGF-1 levels over the 24-week treatment period.
Secondary Outcomes:
- 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, laboratory data, concomitant medication
Total Number to be Enrolled:
140Total Number to be Enrolled at Stanford:
5More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/4/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help