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
  Purpose

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.


Condition Intervention Phase
Carcinoid Syndrome
Drug: Low Dose Part 1
Drug: Mid-Low Dose Part 1
Drug: Mid-High Dose Part 1
Drug: High Dose Part 1
Drug: Part 2 Expanded Cohort
Drug: Placebo
Drug: Open Label Dose Extension
Drug: Open Label Extension 2
Drug: Open Label Extension 3
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Safety (physical examinations, clinical laboratory tests, vitals signs measurements, and ECGs) [ Time Frame: Weekly and biweekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: March 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Part 1
A low dose of LX1606; daily oral intake for 28 days.
Drug: Low Dose Part 1
A low dose of LX1606; daily oral intake for 28 days
Drug: Placebo
Matching placebo dosing with daily oral intake for 28 days
Experimental: Mid-Low Dose Part 1
A mid-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: Placebo
Matching placebo dosing with daily oral intake for 28 days
Experimental: Mid-High Dose Part 1
A mid-high 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: Placebo
Matching placebo dosing with daily oral intake for 28 days
Experimental: High Dose Part 1
A 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: Placebo
Matching placebo dosing with daily oral intake for 28 days
Experimental: Part 2 Expanded Cohort
A dose of LX1606 to an expanded cohort based upon Part 1; 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
Experimental: Open Label Extension 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853047

Locations
United States, Arkansas
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Indiana
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Texas
UT M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Oncology - McAllen
McAllen, Texas, United States, 78503
Texas Oncology - Weslaco
Weslaco, Texas, United States, 78596
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Pablo LaPuerta, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00853047     History of Changes
Other Study ID Numbers: Protocol LX1606.1-202-CS, LX1606.202, LX1032
Study First Received: February 25, 2009
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Carcinoid Tumor
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

ClinicalTrials.gov processed this record on August 26, 2014