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

Sponsor:	Lexicon Pharmaceuticals
Information provided by:	Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00853047

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	Phase II

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:

MedlinePlus related topics: Cancer Carcinoid Tumors

U.S. FDA Resources

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 ]

Estimated Enrollment:	28
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low Dose Part 1: Experimental 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
Mid-Low Dose Part 1: Experimental 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
Mid-High Dose Part 1: Experimental 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
High Dose Part 1: Experimental 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
Part 2 Expanded Cohort: Experimental 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
Open Label Extension: Experimental	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.

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

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

Contacts

Contact: Kenny Frazier, Sr. Dir., Clinical Operations

281-863-3985

Locations

United States, Arkansas
Hematology Oncology Services of Arkansas	Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
United States, Florida
H. Lee Moffitt Cancer Center	Active, not recruiting
Tampa, Florida, United States, 33615
United States, Indiana
St. Francis Medical Group Oncology and Hematology Specialists	Recruiting
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
United States, Nebraska
Nebraska Methodist Hospital	Recruiting
Omaha, Nebraska, United States, 68114
United States, Texas
UT M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Texas Oncology - McAllen	Recruiting
McAllen, Texas, United States, 78503

Sponsors and Collaborators

Lexicon Pharmaceuticals

Investigators

Study Director:

Philip M Brown, MD, JD

Lexicon Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Lexicon Pharmaceuticals, Inc. ( Philip M. Brown, MD, JD/ Senior Vice President, Clinical Development )
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:	August 18, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms

Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug Toxicity
Poisoning
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on August 31, 2010