Effects of Sandostatin LAR® in Acromegaly
Primary Purpose
Acromegaly
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sandostatin LAR
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Sandostatin LAR
Eligibility Criteria
Inclusion Criteria:
- Adults (age > 18 years) with diagnosis of Acromegaly ( previously confirmed by an elevated IGF-1 level)
- IGF-1 concentrations> 10% above the upper limit of normal at screening
- If the patient have undergone surgical resection of a pituitary adenoma, A minimum of two months must have elapsed post surgery prior to enrollment
- May have a history of radiotherapy
- Stable pituitary hormone supplements(x months) prior to baseline visit
if female , ( □ not applicable)
- not pregnant (as evidence by negative serum pregnancy test) or lactating; and
- If childbearing potential, agree to use a medically acceptable form of contraception (such as oral, implantable, or barrier contraception) from the screening, for the duration of the study, and for at least on month after study discontinuation or completion. Childbearing potential is defined as women who are not surgically sterile or not at least one year postmenopausal.
- Sign and date an consent form document indicating that the subject (or legally acceptable representative) has been informed of and agrees to all pertinent aspects of trial
Exclusion Criteria:
- Have other conditions that may result in abnormal GH and/or IGF-1 concentrations (e.g., severe hepatic disease, severe renal disease Malnutrition, treatment with levodopa)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x Upper limit of normal or clinically significant hepatic disease
- Prior somatostatin analog therapy within 6 months of the screening visit
- Other medical therapy for acromegaly for 6 weeks to screening visit
- Visual field defects or other neurological symptoms due to tumor mass
- Have known or suspected drug or alcohol abuse
- Have received an investigational medication within four week prior to screening or is scheduled to received any investigational medication during the study
- Do not have ability to fully comprehend the nature of the study, to follow instructions, cooperate with study procedures, and/or are unable to adhere to the visit scheduled outlined in the protocol
- Have other severe acute or chronic medical or psychiatry condition or Laboratory abnormality that may increase the risk associated with study Participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- Patient who have known hypersensitivity to Sandostatin acetate or other related drug or compound
- Patient with current gallstones
- Patient who have received supraphysiologic doses of glucocorticoid within the past 6 months (except for peri-operative (<3 days duration) of dexamethasone) or who currently received chemotherapeutics agents, or exogenous growth hormone
- Patients who have received other investigational drugs administered or Received within 30 days of study entry
- Patients who exhibit symptoms indicative of intolerance during the 2 weeks Course of Sandostatin injection, s.c
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sandostatin LAR
Arm Description
This is a 9 month, open label dose escalation study of Sandostatin LAR therapy.
Outcomes
Primary Outcome Measures
Change in IGF-1 levels
Secondary Outcome Measures
Change in lab results of cardiovascular risk profile in LAR® treated patients.
Includes C-reactive protein (CRP), IL-6, as well as homocysteine, lipoprotein, and lipid panel results.
Full Information
NCT ID
NCT01424241
First Posted
August 19, 2011
Last Updated
August 8, 2012
Sponsor
Columbia University
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01424241
Brief Title
Effects of Sandostatin LAR® in Acromegaly
Official Title
Metabolic, Cardiovascular and Body Composition Effects of Sandostatin LAR® Therapy of Acromegaly, Effect of Reduction of Serum Insulin-like Growth Factor 1 (IGF-1) Levels Into a New Normative Range
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF1) normalization into current IGF1 normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.
Detailed Description
-Study Purpose: The purpose of this study is to assess the effect of IGFI normalization with Sandostatin LAR® therapy on metabolic abnormalities, cardiovascular risk profile and body composition in patients with active acromegaly.
-Study Design: This is an open label,single center, prospective study. Patients with active acromegaly who have not received prior somatostatin analog therapy will receive sandostatin LAR® for 9 months. Assessments will include laboratory testing, intravenous glucose tolerance tests, signs and symptoms questions, cardiac echocardiography (ECHO) and Dual-emission X-ray absorptiometry (DEXA) body composition before and at the end of the 9 months of therapy.
The primary endpoints of the analysis are change in insulin sensitivity, change in cardiovascular risk marker, change in biochemical markers of the Growth Hormone (GH)/IGF1 axis, change in ECHO determined cardiac parameters and change in body composition such as increase in total body fat or decrease in lean body mass.
Study Subjects A total of 20 subjects total at this site will be enrolled. Subjects will be recruited based on the inclusion and exclusion criteria from the protocol out of the patients who are seen at our Neuroendocrine unit for evaluation of acromegaly.
Recruitment Method Subjects will be recruited from those presenting to the Neuroendocrine Unit for evaluation of acromegaly. Subjects will be recruited by the PI after they have been approached by their physician and expressed an interest in study participation.
Study Procedures Subjects will come to the Neuroendocrine Unit for visits monthly during the study period and administration of study drug. Patients will have their doses titrated based on IGF1 level as per the study protocol. Patients will undergo laboratory testing, physical examinations, ECHO, DEXA and other noninvasive questionnaires and monitoring as specified by the protocol over the course of the study.
Issues Small risks include possible pain and bruising at the site of the needle insertion for blood drawing. Sandostatin LAR® is associated with gastrointestinal side effects such as bloating and diarrhea which usually subside. About 15% of patients treated with this medication develop gallstones. These usually remain asymptomatic. Pituitary tumors may also change in size during these medical therapies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Sandostatin LAR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sandostatin LAR
Arm Type
Experimental
Arm Description
This is a 9 month, open label dose escalation study of Sandostatin LAR therapy.
Intervention Type
Drug
Intervention Name(s)
Sandostatin LAR
Intervention Description
This will be a open label dose escalation study of Sandostatin LAR 10 Mg, 20Mg, 30 Mg up to 40 mg if necessary.
Primary Outcome Measure Information:
Title
Change in IGF-1 levels
Time Frame
Up to 9 months
Secondary Outcome Measure Information:
Title
Change in lab results of cardiovascular risk profile in LAR® treated patients.
Description
Includes C-reactive protein (CRP), IL-6, as well as homocysteine, lipoprotein, and lipid panel results.
Time Frame
Up to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (age > 18 years) with diagnosis of Acromegaly ( previously confirmed by an elevated IGF-1 level)
IGF-1 concentrations> 10% above the upper limit of normal at screening
If the patient have undergone surgical resection of a pituitary adenoma, A minimum of two months must have elapsed post surgery prior to enrollment
May have a history of radiotherapy
Stable pituitary hormone supplements(x months) prior to baseline visit
if female , ( □ not applicable)
not pregnant (as evidence by negative serum pregnancy test) or lactating; and
If childbearing potential, agree to use a medically acceptable form of contraception (such as oral, implantable, or barrier contraception) from the screening, for the duration of the study, and for at least on month after study discontinuation or completion. Childbearing potential is defined as women who are not surgically sterile or not at least one year postmenopausal.
Sign and date an consent form document indicating that the subject (or legally acceptable representative) has been informed of and agrees to all pertinent aspects of trial
Exclusion Criteria:
Have other conditions that may result in abnormal GH and/or IGF-1 concentrations (e.g., severe hepatic disease, severe renal disease Malnutrition, treatment with levodopa)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x Upper limit of normal or clinically significant hepatic disease
Prior somatostatin analog therapy within 6 months of the screening visit
Other medical therapy for acromegaly for 6 weeks to screening visit
Visual field defects or other neurological symptoms due to tumor mass
Have known or suspected drug or alcohol abuse
Have received an investigational medication within four week prior to screening or is scheduled to received any investigational medication during the study
Do not have ability to fully comprehend the nature of the study, to follow instructions, cooperate with study procedures, and/or are unable to adhere to the visit scheduled outlined in the protocol
Have other severe acute or chronic medical or psychiatry condition or Laboratory abnormality that may increase the risk associated with study Participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
Patient who have known hypersensitivity to Sandostatin acetate or other related drug or compound
Patient with current gallstones
Patient who have received supraphysiologic doses of glucocorticoid within the past 6 months (except for peri-operative (<3 days duration) of dexamethasone) or who currently received chemotherapeutics agents, or exogenous growth hormone
Patients who have received other investigational drugs administered or Received within 30 days of study entry
Patients who exhibit symptoms indicative of intolerance during the 2 weeks Course of Sandostatin injection, s.c
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela U Freda, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
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Effects of Sandostatin LAR® in Acromegaly
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