Effects of Sandostatin LAR® in Acromegaly

NCT01424241 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: AAAC0246CSMS995BUS57
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF-1) normalization into current IGF-I normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.

Conditions

Acromegaly

Keywords

Sandostatin LAR

Outcome Measures

Primary Outcomes (1)

• IGF-1 Level on Sandostatin LAR

  Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1)

  Up to 9 months

Secondary Outcomes (3)

• Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels

  Up to 9 months

• Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels

  Up to 9 months

• Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels

  Up to 9 months

Study Arms (1)

Sandostatin LAR

EXPERIMENTAL

Nine months of open label dose escalation Sandostatin LAR therapy.

Drug: Sandostatin LAR

Interventions

Sandostatin LAR DRUG

Open label dose escalation of Sandostatin LAR 10 mg, 20 mg, 30 mg, up to 40 mg if necessary.

Sandostatin LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• Have other conditions that may result in abnormal growth hormone (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.

Sponsors & Collaborators

• Columbia University: lead
• Novartis: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Pamela Freda, MD
• Organization: Columbia University Medical Center

puf1@columbia.edu

212-305-2254

Study Officials

• Pamela U Freda, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 26, 2011
• Study Start: October 1, 2006
• Primary Completion: March 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 24, 2024
• Results First Posted: July 24, 2024

Record last verified: 2024-07

Locations

US (1)