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Acromegaly Combination Treatment Study

Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acromegaly

Intervention: Pegvisomant (Drug); Somatostatin Receptor Ligand (SRL) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Cedars-Sinai Medical Center

Official(s) and/or principal investigator(s):
Shlomo Melmed, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center

Overall contact:
Vivian Hwe, Phone: 424-315-4489, Email: hwev@cshs.org

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, compared to combination high dose SRL and weekly Pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.

Clinical Details

Official title: Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy and High-Dose SRL + Weekly Pegvisomant Therapy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Equivalent Control

Detailed description: The study will begin when the combination of Sandostatin LAR or Somatuline 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 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 48 week treatment period.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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.

Locations and Contacts

Vivian Hwe, Phone: 424-315-4489, Email: hwev@cshs.org

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Vivien Bonert, MD, Sub-Investigator
Additional Information

Starting date: January 2012
Last updated: February 2, 2015

Page last updated: August 23, 2015

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