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Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01104415
First received: April 12, 2010
Last updated: February 20, 2014
Last verified: February 2014

April 12, 2010
February 20, 2014
May 2010
February 2014   (final data collection date for primary outcome measure)
Safety (physical examinations, clinical laboratory tests, vital signs measurements, and ECGs) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Hematology/blood chemistry - weekly, physical examinations - biweekly, vital signs - biweekly, urinalysis - monthly, ECG - monthly
Same as current
Complete list of historical versions of study NCT01104415 on ClinicalTrials.gov Archive Site
  • Number of bowel movements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Flushing episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Subjective global assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Urgency to defecate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Stool form/consistency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood 5-HT levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood Chromagranin-A levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Urinary 5-HIAA levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sensation/severity of nausea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Abdominal pain and discomfort [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome
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

The purpose of the study is to evaluate the safety and tolerability of multi-dose, open-label LX606 in subjects with symptomatic carcinoid syndrome.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Symptoms of Carcinoid Syndrome
  • Drug: Low Dose LX1606 - Day 1 (start)
    150 mg LX1606 given three times daily for 14 days
  • Drug: Mid-low dose LX1606 - Day 15 (start)
    250 mg LX1606 given three times daily for 14 days
  • Drug: Mid-high dose LX1606 - Day 29 (start)
    350 mg LX1606 given three times daily for 14 days
  • Drug: High dose LX1606 - Day 43 (start)
    500 mg LX1606 given three times daily for 14 days
  • Drug: 4-Week Open Label Dose Extension
    Patients will enter 4-week extension period at optimal dose once achieved, based upon clinical response criteria and/or observation of dose-limiting toxicity.
  • Drug: 72-Week Open Label Dose Extension
    Upon completion of the 4-week stable-dose period, eligible subjects will have the option to continue treatment for an additional 72 weeks.
Experimental: LX1606 Open Label Dose Escalation
Interventions:
  • Drug: Low Dose LX1606 - Day 1 (start)
  • Drug: Mid-low dose LX1606 - Day 15 (start)
  • Drug: Mid-high dose LX1606 - Day 29 (start)
  • Drug: High dose LX1606 - Day 43 (start)
  • Drug: 4-Week Open Label Dose Extension
  • Drug: 72-Week Open Label Dose Extension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Not Provided
February 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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
NCT01104415
Protocol LX1606.1-203-CS, LX1606.203, LX1032
No
Lexicon Pharmaceuticals
Lexicon Pharmaceuticals
Not Provided
Study Director: Pablo LaPuerta, MD Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
February 2014

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