Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
Completed · Phase 1
Conditions studied: Neuroendocrine Tumors
In brief
This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
Key facts
- Study ID
- NCT01364415
- Run by
- Novartis Pharmaceuticals
- People needed
- 29
- Starts
- 2011-08-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2020-12-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
- unresectable metastatic NET tumor with measurable disease
- life expectancy ≥ 12 weeks
You may not qualify if…
- Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
- patients with known hypersensitivity to somatostatin analogs
- patients with symptomatic cholelithiasis in the past 2 months
- patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
- patients with known history of hepatitis C or chronic active hepatitis B
- patients with diagnosis of HIV.
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- Cedars Sinai Medical Center Cedars Sinai 4 — Los Angeles, California, United States
- H. Lee Moffitt Cancer Center & Research Institute SC-1 — Tampa, Florida, United States
- Dana Farber Cancer Institute SC-6 — Boston, Massachusetts, United States
- University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr — Houston, Texas, United States
Full record on ClinicalTrials.gov
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