Trial Search Results

Telotristat Etiprate for Carcinoid Syndrome Therapy

Carcinoid syndrome occurs when carcinoid tumors produce too many hormones and other substances that normally circulate throughout your body. The most common symptoms of carcinoid syndrome are diarrhea and redness (flushing) of the face, chest, or back. Other symptoms include changes in the structure of the heart valves that can impair theheart's function (heart valvular lesions) and abdominal pain and cramping. The purpose of this study is to evaluate an investigational drug called LX1606, developed by Lexicon Pharmaceuticals, Inc. Specifically, the study will test whether two different dose levels of LX1606 (250 mg or 500 mg, each given three times daily) improve control of symptoms and are safe in patients with carcinoid syndrome.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Lexicon Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Telotristat etiprate
  • Drug: Placebo

Phase:

Phase 3

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