Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2016 |
| Start Date: | August 2011 |
| End Date: | April 2016 |
A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)
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.
Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics
and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
Inclusion Criteria:
- ≥18 yrs old, histologically confirmed advanced well or moderately differentiated
neuroendocrine tumor/carcinoma
- unresectable metastatic NET tumor with measurable disease
- life expectancy ≥ 12 weeks
Exclusion Criteria:
- 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
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