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Acromegaly Combination Treatment Study

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ClinicalTrials.gov Identifier: NCT01538966
Recruitment Status : Recruiting
First Posted : February 27, 2012
Last Update Posted : October 1, 2020
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 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 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. An MRI will be performed at the conclusion of the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 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
Study Start Date : January 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

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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 Pegviosmant (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 Pegviosmant (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 Pegviosmant (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. Equivalent Control [ Time Frame: 12 months ]
    We will evaluate whether combination low dose SRL and weekly or daily Pegvisomant will attain equivalent control of serum IGF-1 levels at a lowerr cost, compared to combination high dose SRL and weekly pegvisomant; lower doses of therapy will greatly reduce the cost of acromegaly therapy.


Eligibility Criteria
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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


Contacts
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Contact: Vivian Hwe 424-315-4489 hwev@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Sub-Investigator: Vivien Bonert, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Shlomo Melmed, MD Cedars-Sinai Medical Center
More Information
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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
Last Update Posted: October 1, 2020
Last Verified: September 2020
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
Angiopeptin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents