Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoid Syndrome

Thank you

Trial Information

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


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

Type of Study:

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

Outcome Measure:

Change from baseline in number of daily bowel movements

Outcome Time Frame:

Baseline and 12 weeks

Safety Issue:

No

Principal Investigator

Pablo LaPuerta, MD

Investigator Role:

Study Director

Investigator Affiliation:

Lexicon Pharmaceuticals, Inc

Authority:

United States: Food and Drug Administration

Study ID:

LX1606.1-301-CS

NCT ID:

NCT01677910

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Carcinoid Syndrome
  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome
  • Serotonin Syndrome

Name

Location

Lexicon Investigational SiteMobile, Alabama  36604
Lexicon Investigational SiteSan Francisco, California  94115
Lexicon Investigational SiteOrlando, Florida  32806
Lexicon Investigational SiteIowa City, Iowa  52242
Lexicon Investigational SiteLexington, Kentucky  40536
Lexicon Investigational SiteKenner, Louisiana  70112
Lexicon Investigational SiteBoston, Massachusetts  02215
Lexicon Investigational SiteOmaha, Nebraska  68114
Lexicon Investigational SiteNew York, New York  10029
Lexicon Investigational SiteHouston, Texas  77030