Study 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.
Acromegaly Combination Treatment Study
Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy, Low-Dose SRL + Weekly Pegvisomant Therapy, and High-Dose SRL + Weekly Pegvisomant Therapy
2 other identifiers
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedStudy Start
First participant enrolled
March 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedResults Posted
Study results publicly available
January 4, 2023
CompletedJanuary 4, 2023
August 1, 2022
10.1 years
February 21, 2012
November 20, 2022
December 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 weeks
Study Arms (3)
High dose SRL + weekly Pegvisomant
ACTIVE COMPARATORHigh dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)
Low dose SRL + daily Pegvisomant
ACTIVE COMPARATORLow dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)
Low dose SRL + weekly Pegvisomant
ACTIVE COMPARATORLow dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Related Publications (1)
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.
PMID: 32754748RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vivian Hwe
- Organization
- Cedars-Sinai Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Shlomo Melmed, MD
Cedars-Sinai Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Vice President, Academic Affairs
Study Record Dates
First Submitted
February 21, 2012
First Posted
February 27, 2012
Study Start
March 29, 2012
Primary Completion
May 20, 2022
Study Completion
May 20, 2022
Last Updated
January 4, 2023
Results First Posted
January 4, 2023
Record last verified: 2022-08