Phase 2 N=15 Randomized Treatment

Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

Carcinoid Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01104415 ↗

Enrolled (actual)

Serious AEs

38.5%

Results posted

Apr 2018

Primary outcome: Primary: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase — 15; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Telotristat etiprate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lexicon Pharmaceuticals
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Core Phase	15; 5	—
PRIMARY Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Drug-Related TEAEs in the Extension Period	11; 4	—
SECONDARY Change From Baseline in Number of Bowel Movements (BMs)	-2.60; -2.85	—
SECONDARY Change From Baseline in Stool Form/Consistency	-0.79; -1.31	—
SECONDARY Change From Baseline in Percentage of Days With Sensation of Urgency to Defecate	-11.32; -22.79	—
SECONDARY Change From Baseline in Sensation/Severity of Nausea Using 100 mm Visual Analog Scale (VAS)	-2.43; -5.71	—
SECONDARY Number of Participants With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome	10; 4	—
SECONDARY Change From Baseline in Daily Severity of Abdominal Pain or Discomfort Using 100 mm Visual Analog Scale (VAS)	-8.66; -24.11	—
SECONDARY Change From Baseline in Daily Number of Cutaneous Flushing Episodes	-0.88; -1.55	—
SECONDARY Number of Participants Achieving Clinically Meaningful Symptom Reduction in the Core Phase	14	—
SECONDARY Change From Baseline in Urinary 5-Hydroxyindoleacetic Acid (HIAA) Levels	-97.26; -65.02	—

Summary

The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.

Eligibility Criteria

Inclusion Criteria

Males and females, aged 18 and older
Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
Symptomatic carcinoid syndrome (≥4 bowel movements per day)
Ability to provide written informed consent

Exclusion Criteria

≥ 12 high-volume, watery bowel movements per day
Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
Karnofsky status ≤70% - unable to care for self
Surgery within 60 days prior to screening
A history of short bowel syndrome
Life expectancy < 12 months
History of substance or alcohol abuse within 2 years prior to screening
Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01104415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.