Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
Trial ID or NCT#
NCT02026063
Status
NOT RECRUITING
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)
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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
Investigator(s)
George A. Fisher Jr.
Medical oncologist,
Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
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