Telotristat Etiprate for Carcinoid Syndrome Therapy

Not Recruiting

Trial ID: NCT02063659

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

Stanford Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine

Eligibility

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

Intervention(s):

drug: Placebo

drug: Telotristat etiprate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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