Education and Training
Telotristat Etiprate for Carcinoid Syndrome Therapy
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Placebo
- drug: Telotristat etiprate
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting