TerminatedNCT01538966Updated Jan 4, 2023Results posted

Acromegaly Combination Treatment Study

An interventional study of Pegvisomant and Octreotide LAR in Acromegaly, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

Why this study was terminated

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.

Phase: Not applicable
Study type: Interventional
Enrollment: 76
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Acromegaly

Browse trials for

Acromegaly 196

Keywords

acromegaly
pituitary
pegvisomant
somavert
lanreotide
octreotide

In context

Acromegaly

196 studies on the registry are indexed under Acromegaly; 18 are open to participants now.

This study's enrollment of 76 is above the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 76 participants (actual)

Study arms

Active comparator
High dose SRL + weekly Pegvisomant
High dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week)
Drug: Pegvisomant · Drug: Octreotide LAR · Drug: Lanreotide
Active comparator
Low dose SRL + daily Pegvisomant
Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day)
Drug: Pegvisomant · Drug: Octreotide LAR · Drug: Lanreotide
Active comparator
Low dose SRL + weekly Pegvisomant
Low dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week)
Drug: Pegvisomant · Drug: Octreotide LAR · Drug: Lanreotide

Interventions

DrugPegvisomant
Also known as: Somavert
DrugOctreotide LAR
Also known as: Sandostatin
DrugLanreotide
Also known as: Somatuline

What researchers measure

Primary outcomes

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.
Time frame: 24 weeks

Results

Posted Jan 4, 2023

Participant flow

Participant flow — Overall Study
Milestone	High Dose SRL + Weekly Pegvisomant	Low Dose SRL + Daily Pegvisomant	Low Dose SRL + Weekly Pegvisomant
Started	23	26	27
Completed	15	14	23
Not completed	8	12	4

Outcome measures

PrimaryCost 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.

Time frame:: 24 weeks
Reported as:: Mean · US dollars/month

Cost Effectiveness
US dollars/month	High Dose SRL + Weekly Pegvisomant	Low Dose SRL + Daily Pegvisomant	Low Dose SRL + Weekly Pegvisomant
Cost Effectiveness	14,261.33 ± 1,645.49	22,542.86 ± 11,158.49	9,836.52 ± 1,374.99

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
High Dose SRL + Weekly Pegvisomant	0/15 (0%)	0/15 (0%)	4/15 (26.7%)
Low Dose SRL + Daily Pegvisomant	0/14 (0%)	0/14 (0%)	2/14 (14.3%)
Low Dose SRL + Weekly Pegvisomant	0/23 (0%)	1/23 (4.3%)	9/23 (39.1%)

Most frequent serious events

Most frequent serious events
Event	High Dose SRL + Weekly Pegvisomant	Low Dose SRL + Daily Pegvisomant	Low Dose SRL + Weekly Pegvisomant
TuberculosisRespiratory, thoracic and mediastinal disorders	0/15	0/14	1/23
PneumoniaRespiratory, thoracic and mediastinal disorders	0/15	0/14	1/23

Most frequent other events

Most frequent other events
Event	High Dose SRL + Weekly Pegvisomant	Low Dose SRL + Daily Pegvisomant	Low Dose SRL + Weekly Pegvisomant
HeadacheNervous system disorders	4/15	0/14	2/23
FatigueGeneral disorders	0/15	1/14	6/23
Joint painMusculoskeletal and connective tissue disorders	2/15	0/14	4/23
SwellingGeneral disorders	2/15	0/14	1/23
Back painMusculoskeletal and connective tissue disorders	0/15	1/14	3/23
DiarrheaGastrointestinal disorders	1/15	0/14	1/23
NauseaGastrointestinal disorders	1/15	0/14	1/23

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	High Dose SRL + Weekly Pegvisomant	Low Dose SRL + Daily Pegvisomant	Low Dose SRL + Weekly Pegvisomant	Total
Mean	48.6 ± 17.6	52.9 ± 12.1	48.0 ± 13.3	49.5 ± 14.3

Sex: Female, Male
Sex: Female, Male(Participants)	High Dose SRL + Weekly Pegvisomant	Low Dose SRL + Daily Pegvisomant	Low Dose SRL + Weekly Pegvisomant	Total
Female	10	8	14	32
Male	5	6	9	20

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	High Dose SRL + Weekly Pegvisomant	Low Dose SRL + Daily Pegvisomant	Low Dose SRL + Weekly Pegvisomant	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	1	4	5
Native Hawaiian or Other Pacific Islander	0	0	1	1
Black or African American	1	0	0	1
White	14	13	18	45
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Study locations

1 site

Cedars-Sinai Medical Center
Los Angeles, California 90048, United States

References and documents

Publications

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. PubMed 32754748 ↗

Study documents

Protocol and statistical analysis plan · Nov 9, 2022

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01538966
Lead sponsor: Cedars-Sinai Medical Center
Responsible party: Shlomo Melmed, MD (Executive Vice President, Academic Affairs, Cedars-Sinai Medical Center) — Principal investigator
First posted: Feb 27, 2012
Start date: Mar 29, 2012
Primary completion: May 20, 2022
Completion: May 20, 2022
Results posted: Jan 4, 2023
Last update: Jan 4, 2023

Study contacts

Shlomo Melmed, MD

principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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