Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
Lexicon Pharmaceuticals
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00853047
First received: February 25, 2009
Last updated: December 13, 2012
Last verified: December 2012
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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 ]
| Estimated Enrollment: | 28 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
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: | December 13, 2012 |
| 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 Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 23, 2013