Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00446082
First received: March 9, 2007
Last updated: September 28, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoid Tumor Acromegaly |
Drug: Pasireotide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection [ Time Frame: Baseline, D7, D35, D63 ] [ Designated as safety issue: No ]in patients with acromegaly and in patients with carcinoid disease
Secondary Outcome Measures:
- To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection [ Time Frame: Baseline, D7, D35, D63 ] [ Designated as safety issue: No ]in patients with acromegaly and in patients with carcinoid disease.
| Estimated Enrollment: | 77 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SOM230 LAR | Drug: Pasireotide |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria for patients with acromegaly:
- Male or female patients between 18 and 80 years
- Patients with acromegaly due to a pituitary adenoma with elevated GH and IGF-1 concentrations
Exclusion criteria for patients with acromegaly:
- 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
Inclusion criteria for patients with carcinoid disease:
- 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
Exclusion criteria for patients with carcinoid disease:
- 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
Other protocol-defined in- and exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446082
Locations
| United States, California | |
| Cedars Sinai Medical Center SC-3 | |
| Los Angeles, California, United States, 90048 | |
| Stanford University Medical Center Stanford Cancer Center (3) | |
| Stanford, California, United States, 94304 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center/University of South Florida Dept.of H.LeeMoffittCC&RI(1) | |
| Tampa, Florida, United States, 33612 | |
| United States, Texas | |
| MD Anderson Cancer Center/University of Texas Gastrointestinal Med. Oncology | |
| Houston, Texas, United States, 77030-4009 | |
| Belgium | |
| Novartis Investigative Site | |
| Bruxelles, Belgium, 1200 | |
| Novartis Investigative Site | |
| Leuven, Belgium, 3000 | |
| Novartis Investigative Site | |
| Liege, Belgium, 4000 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| London, Ontario, Canada, N6A 4L6 | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G1X5 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Germany | |
| Novartis Investigative Site | |
| Berlin, Germany, 12200 | |
| Novartis Investigative Site | |
| Berlin, Germany, 10098 | |
| Novartis Investigative Site | |
| Essen, Germany, 45122 | |
| Novartis Investigative Site | |
| Leipzig, Germany, 04317 | |
| Novartis Investigative Site | |
| Muenchen, Germany, 80336 | |
| Netherlands | |
| Novartis Investigative Site | |
| Rotterdam, Netherlands, 3015 CE | |
| Norway | |
| Novartis Investigative Site | |
| Oslo, Norway, NO-0424 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Study Chair: | Novartis | Novartis |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00446082 History of Changes |
| Other Study ID Numbers: | CSOM230C2110, 2005-003348-75 |
| Study First Received: | March 9, 2007 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Food and Drug Administration Belgium: Directorate general for the protection of Public health: Medicines Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency |
Keywords provided by Novartis:
|
Refractory/ resistant carcinoid disease acromegaly adults pasireotide LAR |
somatostatin analogue SOM230 pharmacokinetics Refractory or resistant carcinoid disease and acromegaly |
Additional relevant MeSH terms:
|
Acromegaly Carcinoid Tumor Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Endocrine System Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 19, 2013