Clinical Trial: Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: The purpose of this study is to evaluate the safety and tolerability of LX1606 versus a placebo control in subjects with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.

Detailed Summary:
Sponsor: Lexicon Pharmaceuticals

Current Primary Outcome: Safety (physical examinations, clinical laboratory tests, vitals signs measurements, and ECGs) [ Time Frame: Weekly and biweekly ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Symptom diary [ Time Frame: Daily ]
  • Effectiveness (number of bowel movements compared to baseline) [ Time Frame: Daily ]
  • Subjective global assessment [ Time Frame: Weekly ]
  • Effect on biomarker levels in blood (5-HT) [ Time Frame: Weekly ]
  • Effect on biomarker levels in urine (5-HIAA) [ Time Frame: Biweekly ]
  • Chromogranin-A levels in blood [ Time Frame: Biweekly ]


Original Secondary Outcome: Same as current

Information By: Lexicon Pharmaceuticals

Dates:
Date Received: February 25, 2009
Date Started: March 2009
Date Completion:
Last Updated: April 1, 2016
Last Verified: April 2016