Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Lexicon Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01677910
First received: August 30, 2012
Last updated: November 6, 2014
Last verified: November 2014
  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 number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by 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 Not Adequately Controlled by 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 ]
  • Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in urinary 5-hydroxyindoleacetic acid (5-HIAA) levels [ 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 ]

Estimated Enrollment: 105
Study Start Date: October 2012
Estimated Primary Completion Date: March 2016 (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
Experimental: 500 mg telotristat etiprate open label extension
Two 250 mg telotristat etiprate tablets three times daily in a 36-week open-label Extension period
Drug: Telotristat etiprate tablets (250 mg)
Other Name: LX1606

  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
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: NCT01677910

Contacts
Contact: Shanna Jackson, Project manager 281-863-3000 clinicalinfo@lexpharma.com

  Show 70 Study Locations
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: November 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 23, 2014