Trials Sponsors Conditions Drugs Pricing

Conditions

Carcinoid Syndrome

Outcome Measures

Primary Outcomes (1)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug.
First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)

Secondary Outcomes (4)

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit
Baseline, Weeks 24, 48, 72 and 84
Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit
Baseline, Weeks 24, 48, 72 and 84
Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84
Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit
Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84

Study Arms (2)

250 mg Telotristat Etiprate

EXPERIMENTAL

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

Drug: Telotristat etiprate

500 mg Telotristat Etiprate

EXPERIMENTAL

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

Drug: Telotristat etiprate

Interventions

Telotristat etiprateDrug

Telotristat etiprate tablet (250 mg)

Also known as: LX1606

250 mg Telotristat Etiprate500 mg Telotristat Etiprate

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Lexicon Pharmaceuticals
Industrylead

Study Sites (43)

Lexicon Investigational Site

Mobile, Alabama, 36604, United States

Lexicon Investigational Site

Stanford, California, 94305, United States

Lexicon Investigational Site

Iowa City, Iowa, 52242, United States

Lexicon Investigational Site

Lexington, Kentucky, 40536, United States

Lexicon Investigational Site

Boston, Massachusetts, 02215, United States

Lexicon Investigational Site

New York, New York, 10029, United States

Lexicon Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Related Publications (1)

Horsch D, Anthony L, Gross DJ, Valle JW, Welin S, Benavent M, Caplin M, Pavel M, Bergsland E, Oberg K, Kassler-Taub KB, Binder P, Banks P, Lapuerta P, Kulke MH. Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study. Neuroendocrinology. 2022;112(3):298-310. doi: 10.1159/000516958. Epub 2021 May 3.
PMID: 33940581DERIVED

MeSH Terms

Conditions

Serotonin Syndrome

Interventions

telotristat

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Results Point of Contact

Title: Pablo Lapuerta, MD
Organization: Lexicon Pharmaceuticals, Inc.

Study Officials

Pablo Lapuerta, MD
Lexicon Pharmaceuticals, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

124 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 1, 2014

Study Start

January 14, 2014

Actual (reported)

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

250 mg Telotristat Etiprate

500 mg Telotristat Etiprate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

250 mg Telotristat Etiprate

500 mg Telotristat Etiprate

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations