Telotristat Etiprate for Carcinoid Syndrome Therapy

• Status: Completed
• Trial end date: 2016-03-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals

Criteria

Inclusion Criteria:

• Patients ≥ 18 years of age

• All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.

• Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor

• Documented history of carcinoid syndrome

• Patient is able and willing to provide written informed consent prior to participation

Exclusion Criteria:

• Presence of diarrhea attributed to any condition other than carcinoid syndrome.

• Presence of 12 or more watery bowel movements per day

• Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening

• Karnofsky Performance Status ≤ 60%

• Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator

• A history of short bowel syndrome

• History of constipation within 2 years of Screening

• Life expectancy < 12 months from Screening