Acromegaly Combination Treatment Study

December 12, 2022 updated by: Shlomo Melmed, MD, Cedars-Sinai Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Octreotide LAR
Other Names:
  • Sandostatin
Drug: Pegvisomant
Other Names:
  • Somavert
Drug: Lanreotide
Other Names:
  • Somatuline
Active Comparator: Low dose SRL + daily Pegvisomant

Low dose of SRL monthly

  • Octreotide LAR 10mg
  • Lanreotide 60mg

Daily Pegvisomant (15-60mg/day)
Drug: Octreotide LAR
Other Names:
  • Sandostatin
Drug: Pegvisomant
Other Names:
  • Somavert
Drug: Lanreotide
Other Names:
  • Somatuline
Active Comparator: Low dose SRL + weekly Pegvisomant

Low dose of SRL monthly

  • Octreotide LAR 10mg
  • Lanreotide 60mg

Weekly Pegvisomant (40-120mg/week)
Drug: Octreotide LAR
Other Names:
  • Sandostatin
Drug: Pegvisomant
Other Names:
  • Somavert
Drug: Lanreotide
Other Names:
  • Somatuline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Shlomo Melmed, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2012

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

May 20, 2022

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro26424
  • WS2036536 (Other Grant/Funding Number: Pfizer)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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