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Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome

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ClinicalTrials.gov Identifier: NCT01104415
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Symptoms of Carcinoid Syndrome 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) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 12, 2014


Arm Intervention/treatment
Experimental: LX1606 Open Label Dose Escalation 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




Primary Outcome Measures :
  1. Number of Patients With Any Drug-related Treatment-emergent Adverse Event [ Time Frame: Baseline, up to 12 weeks ]
    An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant, participating in a clinical study with study drug, regardless of causal relationship.

  2. Number of Patients With Any Drug-related Treatment-emergent Adverse Event [ Time Frame: 124 weeks ]
    An AE is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant, participating in a clinical study with study drug, regardless of causal relationship.


Secondary Outcome Measures :
  1. Change in Number of Bowel Movements [ Time Frame: Baseline up to Weeks 9-12 ]
    The change from baseline value was calculated as the difference between mean numbers of BMs of the post-baseline interval and baseline.

  2. Change in Weekly Stool Form [ Time Frame: Baseline up to Weeks 9-12 ]
    Assessed using a 6-point scale (0-none, 1-hard, 2-firm, 3-soft, 4-loose, 5-watery). The change from baseline value was calculated as the difference between mean score of the post-baseline interval and baseline.

  3. Change in Proportion of Days With Sensation of Urgency to Defecate [ Time Frame: Baseline up to Weeks 9-12 ]
    The change from baseline value was calculated as the difference between mean percentage of days of the post-baseline interval and baseline.

  4. Change in Sensation/Severity of Nausea [ Time Frame: Baseline up to Weeks 9-12 ]
    Sensation/severity of nausea was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the sensation/severity of nausea experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The change from baseline value was calculated as the difference between mean score of the post-baseline interval and baseline.

  5. Number of Patients With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome [ Time Frame: Weeks 9-12 ]
  6. Change in Daily Severity of Abdominal Pain or Discomfort [ Time Frame: Baseline up to Weeks 9-12 ]
    The mean severity of abdominal pain or discomfort based on a 100-mm VAS scale. The VAS component rates on a scale from 0 millimeter (mm) = worst imaginable to 100 mm =best imaginable higher scores indicate a better health state. The change from baseline value was calculated as the difference between mean score of the post-baseline interval and baseline.

  7. Change in Daily Number of Cutaneous Flushing Episodes [ Time Frame: Baseline up to Weeks 9-12 ]
    Cutaneous flushing response rate derived for each participant using the daily number of cutaneous flushing episodes and defined as follows: a reduction from Baseline in the daily number of cutaneous flushing episodes of ≥30%, and an absence of octreotide rescue treatment during the interval that cutaneous flushing response criteria were met. The change from baseline value was calculated as the difference between mean numbers of cutaneous flushing episodes of the post-baseline interval and baseline.

  8. Change in Urinary 5-Hydroxyindoleacetic Acid (HIAA) [ Time Frame: Week 12 ]
  9. Change in Weekly Bowel Movements [ Time Frame: Baseline up to Week 24 ]
  10. Change in Weekly Stool Form [ Time Frame: Baseline up to Week 24 ]
    Assessed using using a 6-point scale (0-none, 1-hard, 2-firm, 3-soft, 4-loose, 5-watery).

  11. Change From Baseline in Weekly Sensation of Urgency to Defecate [ Time Frame: Baseline to Week 24 ]
  12. Change From Baseline in Weekly Sensation of Nausea [ Time Frame: Baseline to Week 24 ]
  13. Number of Patients Reporting Adequate Relief [ Time Frame: Week 24 ]
  14. Change From Baseline in Weekly Level of Abdominal Pain or Discomfort [ Time Frame: Baseline to Week 24 ]
  15. Change in Number of Cutaneous Flushing Episodes [ Time Frame: Baseline up to Week 24 ]
  16. Change in Urinary 5-Hydroxyindoleacetic Acid (HIAA) [ Time Frame: Baseline to Week 20-21 ]
    The change from baseline value was calculated as the difference between mean change in 5-HIAA of the post-baseline interval and baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104415


Locations
Germany
Lexicon Investigational Site
Bad Berka, Germany
Lexicon Investigational Site
Berlin, Germany
Lexicon Investigational Site
Halle, Germany
Lexicon Investigational Site
Lubeck, Germany
Lexicon Investigational Site
Marburg, Germany
Lexicon Investigational Site
Munich, Germany
United Kingdom
Lexicon Investigational Site
Basingstoke, United Kingdom
Lexicon Investigational Site
Cambridge, United Kingdom
Lexicon Investigational Site
London, United Kingdom
Lexicon Investigational Site
Manchester, United Kingdom
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Pablo LaPuerta, MD Lexicon Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01104415     History of Changes
Other Study ID Numbers: Protocol LX1606.1-203-CS
LX1606.203, LX1032 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
2013-002596-18 ( EudraCT Number )
First Posted: April 15, 2010    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: March 2018

Keywords provided by Lexicon Pharmaceuticals:
Carcinoid syndrome

Additional relevant MeSH terms:
Syndrome
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders