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Acromegaly Combination Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01538966
Recruitment Status : 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.)
First Posted : February 27, 2012
Results First Posted : January 4, 2023
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Shlomo Melmed, MD, Cedars-Sinai Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Pegvisomant Drug: Octreotide LAR Drug: Lanreotide Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy, Low-Dose SRL + Weekly Pegvisomant Therapy, and High-Dose SRL + Weekly Pegvisomant Therapy
Actual Study Start Date : March 29, 2012
Actual Primary Completion Date : May 20, 2022
Actual Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: High dose SRL + weekly Pegvisomant

High dose of SRL monthly

  • Octreotide LAR 30mg
  • Lanreotide 120mg

Weekly Pegvisomant (40-120mg/week)

 Drug: Pegvisomant
Other Name: Somavert

Drug: Octreotide LAR
Other Name: Sandostatin

Drug: Lanreotide
Other Name: Somatuline
Active Comparator: Low dose SRL + daily Pegvisomant

Low dose of SRL monthly

  • Octreotide LAR 10mg
  • Lanreotide 60mg

Daily Pegvisomant (15-60mg/day)

 Drug: Pegvisomant
Other Name: Somavert

Drug: Octreotide LAR
Other Name: Sandostatin

Drug: Lanreotide
Other Name: Somatuline
Active Comparator: Low dose SRL + weekly Pegvisomant

Low dose of SRL monthly

  • Octreotide LAR 10mg
  • Lanreotide 60mg

Weekly Pegvisomant (40-120mg/week)

 Drug: Pegvisomant
Other Name: Somavert

Drug: Octreotide LAR
Other Name: Sandostatin

Drug: Lanreotide
Other Name: Somatuline


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538966


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by Shlomo Melmed, MD, Cedars-Sinai Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] November 9, 2022

More Information
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Publications of Results:

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Responsible Party: Shlomo Melmed, MD, Executive Vice President, Academic Affairs, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01538966    
Other Study ID Numbers: Pro26424
WS2036536 ( Other Grant/Funding Number: Pfizer )
First Posted: February 27, 2012    Key Record Dates
Results First Posted: January 4, 2023
Last Update Posted: January 4, 2023
Last Verified: August 2022
Keywords provided by Shlomo Melmed, MD, Cedars-Sinai Medical Center:
acromegaly
pituitary
pegvisomant
 somavert
lanreotide
octreotide
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Lanreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents