AcromegalyNCT01538966
Acromegaly Combination Treatment Study
A study testing Pegvisomant, Octreotide LAR and Lanreotide in people with Acromegaly, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Pegvisomant, Octreotide LAR and Lanreotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2012to 20 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this 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
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
- Acromegaly
- Being tested
- Pegvisomant, Octreotide LAR, Lanreotide
- Keywords
- acromegaly, pituitary, pegvisomant, somavert, lanreotide, octreotide
- Medical subject headings
- Acromegaly, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegvisomantDrug
Also called Somavert
Octreotide LARDrug
Also called Sandostatin
LanreotideDrug
Also called Somatuline
| Study group | Role | What they receive |
|---|---|---|
| High dose SRL + weekly Pegvisomant | Active comparator | High dose of SRL monthly
* Octreotide LAR 30mg
* Lanreotide 120mg
Weekly Pegvisomant (40-120mg/week) Receives: Drug: Pegvisomant; Drug: Octreotide LAR; Drug: Lanreotide |
| Low dose SRL + daily Pegvisomant | Active comparator | Low dose of SRL monthly
* Octreotide LAR 10mg
* Lanreotide 60mg
Daily Pegvisomant (15-60mg/day) Receives: Drug: Pegvisomant; Drug: Octreotide LAR; Drug: Lanreotide |
| Low dose SRL + weekly Pegvisomant | Active comparator | Low dose of SRL monthly
* Octreotide LAR 10mg
* Lanreotide 60mg
Weekly Pegvisomant (40-120mg/week) Receives: Drug: Pegvisomant; Drug: Octreotide LAR; Drug: Lanreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study start29 Mar 2012
- Primary completion20 May 2022
- Study completion20 May 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shlomo Melmed, MD, Cedars-Sinai Medical Center
- Investigators
- Shlomo Melmed, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538966
- Sponsor's protocol ID
- Pro26424
- Other IDs
- WS2036536
- Status last verified
- Aug 2022
- First submitted
- 21 Feb 2012
- Last updated
- 4 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy, Low-Dose SRL + Weekly Pegvisomant Therapy, and High-Dose SRL + Weekly Pegvisomant Therapy
- ClinicalTrials.gov ID
- NCT01538966
- Acronym / sponsor ID
- Pro26424
- Conditions
- Acromegaly
- Keywords
- acromegaly, pituitary, pegvisomant, somavert, lanreotide, octreotide
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 29 Mar 2012 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Posted 4 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose SRL + weekly Pegvisomant | Active comparator | Drug: Pegvisomant, Drug: Octreotide LAR, Drug: LanreotideHigh dose of SRL monthly * Octreotide LAR 30mg * Lanreotide 120mg Weekly Pegvisomant (40-120mg/week) |
| Low dose SRL + daily Pegvisomant | Active comparator | Drug: Pegvisomant, Drug: Octreotide LAR, Drug: LanreotideLow dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Daily Pegvisomant (15-60mg/day) |
| Low dose SRL + weekly Pegvisomant | Active comparator | Drug: Pegvisomant, Drug: Octreotide LAR, Drug: LanreotideLow dose of SRL monthly * Octreotide LAR 10mg * Lanreotide 60mg Weekly Pegvisomant (40-120mg/week) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegvisomantAlso: Somavert | Drug | High dose SRL + weekly Pegvisomant, Low dose SRL + daily Pegvisomant, Low dose SRL + weekly Pegvisomant |
| Octreotide LARAlso: Sandostatin | Drug | High dose SRL + weekly Pegvisomant, Low dose SRL + daily Pegvisomant, Low dose SRL + weekly Pegvisomant |
| LanreotideAlso: Somatuline | Drug | High dose SRL + weekly Pegvisomant, Low dose SRL + daily Pegvisomant, Low dose SRL + weekly Pegvisomant |
Primary outcome
Cost Effectiveness
Time frame: 24 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32754748Bonert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomo Melmed, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pegvisomant, Octreotide LAR and Lanreotide in people with Acromegaly, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost Effectiveness (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.