A Phase 2, Open-Label, Multi-Center, Serial Ascending Dose, Dose-Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects With Symptomatic Carcinoid Syndrome
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Symptoms of Carcinoid Syndrome
Both
Symptoms of Carcinoid Syndrome
Trial Information
A Phase 2, Open-Label, Multi-Center, Serial Ascending Dose, Dose-Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects With Symptomatic Carcinoid Syndrome
Inclusion Criteria:
- Males and females, aged 18 and older
- Biopsy-proven metastatic carcinoid tumor of the GI tract with disease extent
confirmed by CT, MRI, or radionuclide imaging
- Symptomatic carcinoid syndrome (≥4 bowel movements per day)
- Ability to provide written informed consent
Exclusion Criteria:
- ≥ 12 high-volume, watery bowel movements per day
- Sponsor-unacceptable clinical laboratory values for hematology and liver function
tests at screening
- Karnofsky status ≤70% - unable to care for self
- Surgery within 60 days prior to screening
- A history of short bowel syndrome
- Life expectancy < 12 months
- History of substance or alcohol abuse within 2 years prior to screening
- Administration of any investigational drug within 30 days of screening or any
therapeutic protein or antibody within 90 days of screening
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety (physical examinations, clinical laboratory tests, vital signs measurements, and ECGs)
Outcome Description:
Hematology/blood chemistry - weekly, physical examinations - biweekly, vital signs - biweekly, urinalysis - monthly, ECG - monthly
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Pablo LaPuerta, MD
Investigator Role:
Study Director
Investigator Affiliation:
Lexicon Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
Protocol LX1606.1-203-CS
NCT ID:
NCT01104415
Start Date:
May 2010
Completion Date:
Related Keywords:
- Symptoms of Carcinoid Syndrome
- Carcinoid syndrome
- Carcinoid Tumor
- Malignant Carcinoid Syndrome
- Serotonin Syndrome
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