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Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
Not Recruiting
Trial ID: NCT02026063
Purpose
The primary objective of this study is to evaluate the long-term safety and tolerability of
orally administered telotristat etiprate.
Official Title
A Multicenter, Long-term Extension Study to Further Evaluate the Safety and Tolerability of Telotristat Etiprate (LX1606)
Stanford Investigator(s)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Eligibility
Inclusion Criteria:
- Ongoing participation in a Phase 2 [LX1606.1-202-CS (NCT00853047), LX1606.1-203-CS
(NCT01104415)] or Phase 3 [LX1606.1-301-CS (NCT01677910), LX1606.1-303-CS
(NCT02063659)] 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
Intervention(s):
drug: Telotristat etiprate
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061