Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Trial ID or NCT#

NCT02026063

Status

not recruiting iconNOT 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: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

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Contact

CCTO
650-498-7061