Telotristat Etiprate for Carcinoid Syndrome Therapy (TELECAST)

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Carcinoid Syndrome

Treatments: Drug: Placebo; Drug: Telotristat etiprate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02063659

2013-001543-31 (EudraCT Number)

LX1606.303 (Other Identifier)

LX1606.1-303-CS

Details and patient eligibility

About

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years of age
• All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.
• Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
• Documented history of carcinoid syndrome
• Patient is able and willing to provide written informed consent prior to participation

Exclusion criteria

• Presence of diarrhea attributed to any condition other than carcinoid syndrome.
• Presence of 12 or more watery bowel movements per day
• Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
• Karnofsky Performance Status ≤ 60%
• Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
• A history of short bowel syndrome
• History of constipation within 2 years of Screening
• Life expectancy < 12 months from Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 3 patient groups, including a placebo group

250 mg Telotristat Etiprate

Experimental group

Description:

Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for 12 weeks, followed by a 36 week open-label extension period.

Treatment:

Drug: Placebo

Drug: Telotristat etiprate

500 mg Telotristat Etiprate

Experimental group

Description:

Following a 3 to 4-week run-in period, participants were randomized to receive one 250 mg telotristat etiprate tablet and one placebo-matching telotristat etiprate tablet administered three times daily for one week, followed by two 250 mg telotristat etiprate tablets administered three times daily for 11 weeks in the 12 week double-blind treatment period, followed by a 36 week open-label extension period.

Treatment:

Drug: Placebo

Drug: Telotristat etiprate

Placebo

Placebo Comparator group

Description:

Following a 3 to 4-week run-in period, participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks, followed by a 36 week open-label extension period.

Treatment:

Drug: Placebo