Status:
COMPLETED
Study of Pasireotide Long Acting Release (LAR) Injection in Patients With Acromegaly and Patients With Carcinoid Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Carcinoid Tumor
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00446082
Start Date
June 1 2006
End Date
November 1 2013
Last Update
December 21 2020
Active Locations (17)
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1
Cedars Sinai Medical Center SC - 4
Los Angeles, California, United States, 90048
2
Stanford University Medical Center Stanford Cancer Center (3)
Stanford, California, United States, 94304
3
H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1)
Tampa, Florida, United States, 33612
4
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, United States, 77030-4009