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Acromegaly Combination Treatment Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Shlomo Melmed, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01538966
First received: February 21, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Acromegaly
Drug: Pegvisomant
Drug: Somatostatin Receptor Ligand (SRL)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy and High-Dose SRL + Weekly Pegvisomant Therapy

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Equivalent Control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will evaluate whether combination low dose 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 the cost of acromegaly therapy.


Estimated Enrollment: 51
Study Start Date: January 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose SRL + weekly Pegvisomant

High dose of SRL monthly

  • Sandostatin 30mg
  • Lanreotide 120mg

Weekly Pegviosmant (40-90mg/week)

Drug: Pegvisomant
Other Name: Somavert
Drug: Somatostatin Receptor Ligand (SRL)
Other Names:
  • Sandostatin
  • Somatuline
  • Octreotide
  • Lanreotide
Active Comparator: Low dose SRL + daily Pegvisomant

Low dose of SRL monthly

  • Sandostatin 10mg
  • Lanreotide 60mg

Daily Pegviosmant (15-40mg/day)

Drug: Pegvisomant
Other Name: Somavert
Drug: Somatostatin Receptor Ligand (SRL)
Other Names:
  • Sandostatin
  • Somatuline
  • Octreotide
  • Lanreotide
Active Comparator: Low dose SRL + weekly Pegvisomant

Low dose of SRL monthly

  • Sandostatin 10mg
  • Lanreotide 60mg

Weekly Pegviosmant (40-90mg/week)

Drug: Pegvisomant
Other Name: Somavert
Drug: Somatostatin Receptor Ligand (SRL)
Other Names:
  • Sandostatin
  • Somatuline
  • Octreotide
  • Lanreotide

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538966

Contacts
Contact: Vivian Hwe 424-315-4489 hwev@cshs.org
Contact: Billy Gellepis, CCRP 310-423-3395 gellepisw@cshs.org

Locations
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
  More Information

No publications provided

Responsible Party: Shlomo Melmed, MD, Senior Vice President, Academic Affairs, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01538966     History of Changes
Other Study ID Numbers: CSMCIRB 26424, WS2036536
Study First Received: February 21, 2012
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
acromegaly
pituitary
pegvisomant
somavert
lanreotide
octreotide

Additional relevant MeSH terms:
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Angiopeptin
Lanreotide
Somatostatin
Antineoplastic Agents
Cardiovascular Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014