Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms (TELEPATH)

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Carcinoid Syndrome

Treatments: Drug: Telotristat etiprate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02026063

LX1606.302 (Other Identifier)

2013-002596-18 (EudraCT Number)

LX1606.1-302-CS

Details and patient eligibility

About

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

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

250 mg Telotristat Etiprate

Experimental group

Description:

One telotristat etiprate (250 mg) tablet administered three times daily.

Treatment:

Drug: Telotristat etiprate

500 mg Telotristat Etiprate

Experimental group

Description:

Two telotristat etiprate (250 mg) tablets administered three times daily.

Treatment:

Drug: Telotristat etiprate