Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease

NCT00446082 | Completed Phase 1

• 2 other identifiers: CSOM230C21102005-003348-75
• Study Type: interventional
• Target: 85
• Locations: 6 countries
• Sites: 17

Brief Summary

This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease

Conditions

Carcinoid Tumor; Acromegaly

Keywords

Refractory/ resistant carcinoid disease; acromegaly; adults; pasireotide LAR; somatostatin analogue; SOM230; pharmacokinetics; Refractory or resistant carcinoid disease and acromegaly

Outcome Measures

Primary Outcomes (1)

• Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection

  in patients with acromegaly and in patients with carcinoid disease

  Baseline, D7, D35, D63

Secondary Outcomes (1)

• To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection

  Baseline, D7, D35, D63

Study Arms (1)

SOM230 LAR

EXPERIMENTAL

Drug: Pasireotide

Interventions

Pasireotide DRUG

SOM230 LAR

Eligibility Criteria

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

You may qualify if:

• Male or female patients between 18 and 80 years
• Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1 concentrations

You may not qualify if:

• Patients with compression of the optic chiasm causing any visual field defect
• Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start
• Female patients who are pregnant or lactating
• Male or female patients aged ≥18 years
• Patients with histologically confirmed, metastatic carcinoid tumors of the digestive system
• Patients with elevation of chromogranin-A (CgA) and/or serotonin
• Patients who are not adequately controlled by somatostatin analogues
• Specific criteria apply for patients who have received certain types of therapies such as radiotherapies, surgeries, chemo- or immunotherapies in the months prior to study start
• Female patients who are pregnant or lactating

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Cedars Sinai Medical Center SC - 4

Los Angeles, California, 90048, United States

Location

Stanford University Medical Center Stanford Cancer Center (3)

Stanford, California, 94304, United States

Location

H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)

Tampa, Florida, 33612, United States

Location

University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology

Houston, Texas, 77030-4009, United States

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

London, Ontario, N6A 4L6, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G1X5, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2L 4M1, Canada

Location

Novartis Investigative Site

Berlin, 10098, Germany

Location

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Essen, 45122, Germany

Location

Novartis Investigative Site

Leipzig, 04317, Germany

Location

Novartis Investigative Site

München, 80336, Germany

Location

Novartis Investigative Site

Rotterdam, 3015 CE, Netherlands

Location

Novartis Investigative Site

Oslo, NO-0379, Norway

Location

Related Publications (1)

• Petersenn S, Bollerslev J, Arafat AM, Schopohl J, Serri O, Katznelson L, Lasher J, Hughes G, Hu K, Shen G, Resendiz KH, Giannone V, Beckers A. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study. J Clin Pharmacol. 2014 Nov;54(11):1308-17. doi: 10.1002/jcph.326. Epub 2014 May 24.

  PMID: 24800725 RESULT

Related Links

• Novartis Clinical Trial Results for CSOM230C2110

MeSH Terms

Conditions

Carcinoid Tumor; Acromegaly

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 12, 2007
• Study Start: June 1, 2006
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 21, 2020

Record last verified: 2016-11

Locations

NL (1); US (4); BE (3); DE (5); NO (1); CA (3)