Carcinoid Syndrome MedDRA version: 19.1 Level: PT Classification code 10007270 Term: Carcinoid syndrome System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Name: Telotristat Etiprate
Product Code: LX1606
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Telotristat Etiprate
Sponsors
Lexicon Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be considered eligible to participate in the study: 1. Ongoing participation in a Phase 2 study (ie, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 study (ie, LX1606.1-301-CS, LX1606.1-303-CS) study 2. Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of 50 IU/L at Baseline Day 1 are confirmatory in the absence of a clear postmenopausal history. 3. Ability and willingness to provide written informed consent prior to participation in any study-related procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 91 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participating in the study: 1. Major protocol violations in regard to dosing compliance or telotristat etiprate tolerability concerns in a Phase 2 study (ie, LX1606.1-202-CS, LX1606.1-203-CS) or Phase 3 study (ie, LX1606.1-301-CS, LX1606.1-303-CS) study 2. Positive pregnancy test 3. Presence of any clinically significant findings at entry for medical history, laboratory values, or physical examination (relative to patient population) that, in the Investigator’s or Medical Monitor’s opinion, would compromise patient safety or the outcome of the study 4. Patients who are currently committed to an institution by virtue of an order issued either by judicial or adminstrative authorities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: at each visit and the final analysis will be done at the end of the study;Main Objective: The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate ;Secondary Objective: To evaluate changes in patients’ quality of life (QOL) through week 84; Primary end point(s): The primary endpoint is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is to evaluate changes in patients' QOL over 84 weeks of therapie. Safety endpoints are as follows: • Incidence of TEAEs, suspected adverse reaction, AEs leading to discontinuation from the study, SAEs, and deaths • Actual and change from Baseline in clinical laboratory results • Actual and change from Baseline in vital signs results • Actual and change from Baseline in physical examinations • Actual and change from Baseline in ECG findings ;Timepoint(s) of evaluation of this end point: at each visit and the final analysis will be done at the end of the study | — |
Countries
Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactPenny Logan
Lexicon Pharmaceuticals, Inc.
Outcome results
None listed