Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01538966
Status:
TERMINATED
Last Update Posted:
2023-01-04
First Post:
2012-02-21
Brief Title:
Acromegaly Combination Treatment Study
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Comparison of Combination Low-Dose SRL Daily Pegvisomant Therapy Low-Dose SRL Weekly Pegvisomant Therapy and High-Dose SRL Weekly Pegvisomant Therapy
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WS2036536 | OTHER_GRANT | Pfizer | None |