Trial record 17 of 39 for:
Open Studies | "Carcinoid Tumor"
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Refractory Carcinoid Syndrome)
This study is currently recruiting participants.
Verified May 2013 by Lexicon Pharmaceuticals
Sponsor:
Lexicon Pharmaceuticals
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01677910
First received: August 30, 2012
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the change from baseline in the number of daily bowel movements (BMs) averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients refractory to current SSA therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoid Syndrome |
Drug: Telotristat etiprate tablets (250 mg) Drug: Placebo tablets |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Placebo-controlled, Parallel Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome Refractory to Somatostatin Analog (SSA) Therapy |
Resource links provided by NLM:
Further study details as provided by Lexicon Pharmaceuticals:
Primary Outcome Measures:
- Change from baseline in number of daily bowel movements [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in stool consistency [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in the number of cutaneous flushing episodes [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in abdominal pain [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change in the frequency of rescue short-acting somatostatin analog [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 105 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 250 mg telotristat etiprate
One telotristat etiprate (250 mg) tablet administered three times daily
|
Drug: Telotristat etiprate tablets (250 mg)
Other Name: LX1606
|
|
Experimental: 500 mg telotristat etiprate
Two telotristat etiprate (250 mg) tablets administered three times daily
|
Drug: Telotristat etiprate tablets (250 mg)
Other Name: LX1606
|
|
Placebo Comparator: Placebo
Placebo administered three times daily
|
Drug: Placebo tablets
One placebo tablet administered three times daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
- Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements per day during the Run-in period
- Currently receiving stable-dose somatostatin analog (SSA) therapy
Minimum dose of LAR or depot SSA therapy
- Octreotide LAR at 30 mg every 4 weeks
- Lanreotide Depot at 120 mg every 4 weeks
- Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome
- Karnofsky Performance status ≤60%
- Treatment with any tumor directed therapy, including interferon, chemotherapy, mTOR inhibitors ≤4 weeks prior to Screening, or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking ≤12 weeks prior to Screening
- History of short bowel syndrome (SBS)
- Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study, or QTcF >450 ms
- Previous exposure to telotristat etiprate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677910
Contacts
| Contact: Jessica Jackson, Program manager | 281-863-3000 | clinicalinfo@lexpharma.com |
Locations
| United States, Alabama | |
| Lexicon Investigational Site | Recruiting |
| Mobile, Alabama, United States, 36604 | |
| United States, California | |
| Lexicon Investigational Site | Not yet recruiting |
| San Francisco, California, United States, 94115 | |
| Lexicon Investigational Site | Recruiting |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Lexicon Investigational Site | Recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Iowa | |
| Lexicon Investigational Site | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Lexicon Investigational Site | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| United States, Louisiana | |
| Lexicon Investigational Site | Not yet recruiting |
| Kenner, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Lexicon Investigational Site | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| United States, Nebraska | |
| Lexicon Investigational Site | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Lexicon Investigational Site | Not yet recruiting |
| New York, New York, United States, 10029 | |
| United States, Texas | |
| Lexicon Investigational Site | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Lexicon Investigational Site | Not yet recruiting |
| McAllen, Texas, United States, 78503 | |
| Spain | |
| Lexicon Investigational Site | Recruiting |
| Barcelona, Spain | |
| United Kingdom | |
| Lexicon Investigational Site | Recruiting |
| Basingstoke-Hampshire, United Kingdom | |
| Lexicon Investigational Site | Recruiting |
| London, United Kingdom | |
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: | NCT01677910 History of Changes |
| Other Study ID Numbers: | LX1606.1-301-CS, LX1606.301 |
| Study First Received: | August 30, 2012 |
| Last Updated: | May 20, 2013 |
| 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 Somatostatin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013