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Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoid Syndrome

Thank you

Trial Information


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

- Symptoms not managed by stable-dose long-acting octreotide therapy (≥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

- Previous exposure to a tryptophan hydroxylase (TPH) inhibitor

- 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:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Safety (physical examinations, clinical laboratory tests, vitals signs measurements, and ECGs)

Outcome Time Frame:

Weekly and biweekly

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 LX1606.1-202-CS

NCT ID:

NCT00853047

Start Date:

March 2009

Completion Date:

December 2013

Related Keywords:

  • Carcinoid Syndrome
  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome
  • Serotonin Syndrome

Name

Location

University of IowaIowa City, Iowa  52242
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Hematology Oncology Services of ArkansasLittle Rock, Arkansas  72205
Nebraska Methodist HospitalOmaha, Nebraska  68114
Dana Farber Cancer InstituteBoston, Massachusetts  02115
UT M.D. Anderson Cancer CenterHouston, Texas  77030
St. Francis Medical Group Oncology and Hematology SpecialistsIndianapolis, Indiana  46237
Texas Oncology - McAllenMcAllen, Texas  78503
Texas Oncology - WeslacoWeslaco, Texas  78596