Acromegaly Combination Treatment Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01538966 |
Recruitment Status :
Recruiting
First Posted : February 27, 2012
Last Update Posted : October 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acromegaly | Drug: Pegvisomant Drug: Octreotide LAR Drug: Lanreotide | Not Applicable |
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 (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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: High dose SRL + weekly Pegvisomant
High dose of SRL monthly
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
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
Weekly Pegviosmant (40-120mg/week) |
Drug: Pegvisomant
Other Name: Somavert Drug: Octreotide LAR Other Name: Sandostatin Drug: Lanreotide Other Name: Somatuline |
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Vivian Hwe | 424-315-4489 | hwev@cshs.org |
United States, California | |
Cedars-Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048 | |
Sub-Investigator: Vivien Bonert, MD |
Principal Investigator: | Shlomo Melmed, MD | Cedars-Sinai Medical Center |
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 |
acromegaly pituitary pegvisomant |
somavert lanreotide octreotide |
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 |