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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00853047
First received: February 25, 2009
Last updated: July 11, 2014
Last verified: July 2014

February 25, 2009
July 11, 2014
March 2009
June 2014   (final data collection date for primary outcome measure)
Safety (physical examinations, clinical laboratory tests, vitals signs measurements, and ECGs) [ Time Frame: Weekly and biweekly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00853047 on ClinicalTrials.gov Archive Site
  • Symptom diary [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Effectiveness (number of bowel movements compared to baseline) [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Subjective global assessment [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Effect on biomarker levels in blood (5-HT) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Effect on biomarker levels in urine (5-HIAA) [ Time Frame: Biweekly ] [ Designated as safety issue: No ]
  • Chromogranin-A levels in blood [ Time Frame: Biweekly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carcinoid Syndrome
  • Drug: Low Dose Part 1
    A low dose of LX1606; daily oral intake for 28 days
  • Drug: Mid-Low Dose Part 1
    A mid-low dose of LX1606; daily oral intake for 28 days
  • Drug: Mid-High Dose Part 1
    A mid-high dose of LX1606; daily oral intake for 28 days
  • Drug: High Dose Part 1
    A high dose of LX1606; daily oral intake for 28 days
  • Drug: Part 2 Expanded Cohort
    A dose of LX1606 to an expanded cohort based upon Part 1; daily oral intake for 28 days
  • Drug: Placebo
    Matching placebo dosing with daily oral intake for 28 days
  • Drug: Open Label Dose Extension
    Patients can enter an eight-week extension period at current dose based upon qualification.
  • Drug: Open Label Extension 2
    Patients can enter a 24-week extension period at current dose after the 8-week open-label extension period.
  • Drug: Open Label Extension 3
    Patients can enter a 48-week extension period at current dose after the 8-week open-label extension period and the 24-week open-label extension period.
  • Experimental: Low Dose Part 1
    A low dose of LX1606; daily oral intake for 28 days.
    Interventions:
    • Drug: Low Dose Part 1
    • Drug: Placebo
  • Experimental: Mid-Low Dose Part 1
    A mid-low dose of LX1606; daily oral intake for 28 days
    Interventions:
    • Drug: Mid-Low Dose Part 1
    • Drug: Placebo
  • Experimental: Mid-High Dose Part 1
    A mid-high dose of LX1606; daily oral intake for 28 days
    Interventions:
    • Drug: Mid-High Dose Part 1
    • Drug: Placebo
  • Experimental: High Dose Part 1
    A high dose of LX1606; daily oral intake for 28 days
    Interventions:
    • Drug: High Dose Part 1
    • Drug: Placebo
  • Experimental: Part 2 Expanded Cohort
    A dose of LX1606 to an expanded cohort based upon Part 1; daily oral intake for 28 days
    Interventions:
    • Drug: Part 2 Expanded Cohort
    • Drug: Placebo
  • Experimental: Open Label Extension
    Interventions:
    • Drug: Open Label Dose Extension
    • Drug: Open Label Extension 2
    • Drug: Open Label Extension 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00853047
Protocol LX1606.1-202-CS, LX1606.202, LX1032
No
Lexicon Pharmaceuticals
Lexicon Pharmaceuticals
Not Provided
Study Director: Pablo LaPuerta, MD Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP