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Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Status: Recruiting
Phase:
Diagnosis: Gastrointestinal Malignancies, Neuroendocrine/Carcinoid
NCT ID: NCT02026063 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-087

 

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Matthew Kulke, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

Inclusion Criteria: - Ongoing participation in a Phase 2 (LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (LX1606.1-301-CS, LX1606.1-303-CS) study - Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit. - Ability and willingness to provide written informed consent Exclusion Criteria: - Major protocol violations or tolerability concerns in a Phase 2 (eg, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 (eg, LX1606.1-301-CS, LX1606.1-303-CS) study - Positive pregnancy test - Presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination
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