Acromegaly Combination Treatment Study

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Acromegaly Combination Treatment 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

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.

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 Type

Interventional

Primary Outcome

Equivalent Control

Condition

Acromegaly

Intervention

Pegvisomant

Study Arms / Comparison Groups

 High dose SRL + weekly Pegvisomant
Description:  High dose of SRL monthly
Octreotide LAR 30mg
Lanreotide 120mg
Weekly Pegviosmant (40-120mg/week)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

76

Start Date

January 2012

Completion Date

June 2022

Primary Completion Date

December 2021

Eligibility 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.

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Shlomo Melmed, MD, 424-315-4489, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01538966

Organization ID

Pro26424

Secondary IDs

WS2036536

Responsible Party

Principal Investigator

Study Sponsor

Cedars-Sinai Medical Center

Study Sponsor

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

Verification Date

September 2021