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Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

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Lexicon Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Carcinoid Syndrome

Treatments

Drug: Placebo
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot

Study type

Interventional

Funder types

Industry

Identifiers

NCT00853047
LX1606.202 (Other Identifier)
LX1606.1-202-CS

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males and females, aged 18 and older
  • Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (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 associated with a clinical syndrome of volume contraction, dehydration, or hypotension compatible with a "pancreatic cholera"-type clinical syndrome
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

23 participants in 6 patient groups

Telotristat Etiprate 150 mg Core Phase
Experimental group
Description:
Telotristat etiprate capsules,150 mg orally 3 times daily for 28 days in the double-blind treatment period (core phase) in combination with stable-dose octreotide long-acting release (LAR) depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Treatment:
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Telotristat Etiprate 250 mg Core Phase
Experimental group
Description:
Telotristat etiprate capsules, 250 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Treatment:
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Telotristat Etiprate 350 mg Core Phase
Experimental group
Description:
Telotristat etiprate capsules, 350 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Treatment:
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Telotristat Etiprate 500 mg Core Phase
Experimental group
Description:
Telotristat etiprate capsules, 500 mg orally 3 times daily for 28 days in the double-blind treatment period in combination with a stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to enter the optional open-label extension period.
Treatment:
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot
Placebo Core Phase
Experimental group
Description:
Placebo-matching telotristat etiprate capsules, orally 3 times daily for 28 days in the double-blind treatment period in combination with stable-dose octreotide LAR depot therapy given once per month. Upon completion of 28-days of treatment, participants were eligible to receive telotristat etiprate in the optional open-label extension period.
Treatment:
Drug: Placebo
Drug: Octreotide LAR Depot
Telotristat Etiprate Open-Label Extension Phase
Experimental group
Description:
Telotristat etiprate at assigned dose level for 8 weeks in combination with stable-dose octreotide LAR depot therapy given once per month in the open-label extension period. Upon completion of the 8-week period, participants could enter an additional extension period of 172 weeks, receiving telotristat etiprate at the assigned dose or maximum tolerated dose (500 mg 3 times daily).
Treatment:
Drug: Telotristat etiprate
Drug: Octreotide LAR Depot

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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