Back to resultsAcromegaly Combination Treatment Study
Primary Purpose
Acromegaly
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pegvisomant
Octreotide LAR
Lanreotide
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring acromegaly, pituitary, pegvisomant, somavert, lanreotide, octreotide
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed patients with acromegaly who have not had surgery or medical therapy
- Acromegaly patients who are at least 3 months post surgery, who are/are not receiving adjuvant medical therapy
- Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels
- Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.
- Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist.
- Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant (daily or weekly
- Normal liver function tests before randomization to treatment
- The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy.
Exclusion Criteria:
- The patient harbors a macroadenoma with visual field defects due to chiasmatic compression
- The patient has clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit of normal at the baseline visit.
- The patient had pituitary surgery within 3 months prior to study entry
- The patient had radiotherapy within 12 months prior to study entry
- The patient has abnormal CBC and chemistry panel at the baseline visit, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety.
- The patient has a known hypersensitivity to any of the test materials or related compounds.
- The patient has a history of, or known current problems with alcohol or drug abuse.
- The patient has any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
Sites / Locations
- Cedars-Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
High dose SRL + weekly Pegvisomant
Low dose SRL + daily Pegvisomant
Low dose SRL + weekly Pegvisomant
Arm Description
High dose of SRL monthly Octreotide LAR 30mg Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)
Low dose of SRL monthly Octreotide LAR 10mg Lanreotide 60mg Daily Pegvisomant (15-60mg/day)
Low dose of SRL monthly Octreotide LAR 10mg Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
Outcomes
Primary Outcome Measures
Cost Effectiveness
We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels.
Secondary Outcome Measures
Full Information
NCT ID
NCT01538966
First Posted
February 21, 2012
Last Updated
December 12, 2022
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01538966
Brief Title
Acromegaly Combination Treatment Study
Official Title
Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy, Low-Dose SRL + Weekly Pegvisomant Therapy, and High-Dose SRL + Weekly Pegvisomant Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Review of the 12-month data showed patients who deviated from protocol with full IRB monitoring and reporting could not be optimally analyzed. Reopening the study for new enrollment is not feasible and the study was terminated with IRB approval.
Study Start Date
March 29, 2012 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study the investigators will evaluate whether combination low dose somatostatin receptor ligand (SRL) and weekly or daily pegvisomant will attain equivalent control of serum insulin-like growth factor (IGF)-1 levels at a lower cost, compared to combination high dose SRL and weekly pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.
Detailed Description
Subjects will be stratified based on prior response to SRL therapy and then randomized to one of three treatment arms. The study will begin when the combination of octreotide long-acting release (LAR) or lanreotide and pegvisomant is first administered. Study visits will occur every 4 weeks from the start of the study. However, for subjects who cannot make every study visit due to distance, the study team will facilitate monthly blood draws at their local Quest laboratory facility.
After the 24 weeks of combination therapy, subjects with a controlled IGF-1 will then start pegvisomant monotherapy at the same dose and schedule that they attained normalization in combination therapy. IGF-1 levels, liver function test, and blood glucose will be performed monthly. Magnetic resonance imaging (MRI) will be performed at the conclusion of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
acromegaly, pituitary, pegvisomant, somavert, lanreotide, octreotide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose SRL + weekly Pegvisomant
Arm Type
Active Comparator
Arm Description
High dose of SRL monthly
Octreotide LAR 30mg
Lanreotide 120mg
Weekly Pegvisomant (40-120mg/week)
Arm Title
Low dose SRL + daily Pegvisomant
Arm Type
Active Comparator
Arm Description
Low dose of SRL monthly
Octreotide LAR 10mg
Lanreotide 60mg
Daily Pegvisomant (15-60mg/day)
Arm Title
Low dose SRL + weekly Pegvisomant
Arm Type
Active Comparator
Arm Description
Low dose of SRL monthly
Octreotide LAR 10mg
Lanreotide 60mg
Weekly Pegvisomant (40-120mg/week)
Intervention Type
Drug
Intervention Name(s)
Pegvisomant
Other Intervention Name(s)
Somavert
Intervention Type
Drug
Intervention Name(s)
Octreotide LAR
Other Intervention Name(s)
Sandostatin
Intervention Type
Drug
Intervention Name(s)
Lanreotide
Other Intervention Name(s)
Somatuline
Primary Outcome Measure Information:
Title
Cost Effectiveness
Description
We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed patients with acromegaly who have not had surgery or medical therapy
Acromegaly patients who are at least 3 months post surgery, who are/are not receiving adjuvant medical therapy
Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels
Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.
Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist.
Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant (daily or weekly
Normal liver function tests before randomization to treatment
The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy.
Exclusion Criteria:
The patient harbors a macroadenoma with visual field defects due to chiasmatic compression
The patient has clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit of normal at the baseline visit.
The patient had pituitary surgery within 3 months prior to study entry
The patient had radiotherapy within 12 months prior to study entry
The patient has abnormal CBC and chemistry panel at the baseline visit, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety.
The patient has a known hypersensitivity to any of the test materials or related compounds.
The patient has a history of, or known current problems with alcohol or drug abuse.
The patient has any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlomo Melmed, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32754748
Citation
Bonert V, Mirocha J, Carmichael J, Yuen KCJ, Araki T, Melmed S. Cost-Effectiveness and Efficacy of a Novel Combination Regimen in Acromegaly: A Prospective, Randomized Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9):dgaa444. doi: 10.1210/clinem/dgaa444.
Results Reference
result
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Acromegaly Combination Treatment Study
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