Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)

Status: Recruiting
Phase: Phase 1
Diagnosis: Gastrointestinal Malignancies, Neuroendocrine/Carcinoid
NCT ID: NCT01364415 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-186

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Jennifer Ang Chan, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David P. Ryan, MD, Massachusetts General Hospital

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

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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