Telotristat Etiprate for Carcinoid Syndrome Therapy
Trial ID or NCT#
NCT02063659
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase 3, Randomized, Placebo-controlled, Multicenter, Double-blind Study to Evaluate the Safety and Efficacy of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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
Investigator(s)
George A. Fisher Jr.
Medical oncologist,
Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
