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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Carcinoid Syndrome

Treatments: Drug: Telotristat etiprate; Drug: Placebo-matching telotristat etiprate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01677910

LX1606.301 (Other Identifier)

2012-003460-47 (EudraCT Number)

LX1606.1-301-CS

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 long-acting release (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, mechanistic target of rapamycin (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
• Previous exposure to telotristat etiprate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 4 patient groups, including a placebo group

250 mg Telotristat Etiprate

Experimental group

Description:

Following a 3 to 4-week run-in period on stable-dose somatostatin analog (SSA) therapy (octreotide or lanreotide) participants were randomized to receive one 250 mg telotristat etiprate tablet plus one placebo-matching telotristat etiprate tablet administered three times daily for 12 Weeks in the double-blind treatment period, followed by a 36 week open-label extension period.

Treatment:

Drug: Placebo-matching telotristat etiprate

Drug: Telotristat etiprate

500 mg Telotristat Etiprate

Experimental group

Description:

Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive, one telotristat etiprate 250 mg plus one placebo-matching telotristat etiprate tablet administered 3 times daily for 1 week, followed by two telotristat etiprate (250 mg) tablets administered three times daily for 11 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.

Treatment:

Drug: Placebo-matching telotristat etiprate

Drug: Telotristat etiprate

Placebo

Placebo Comparator group

Description:

Following a 3 to 4-week run-in period on stable-dose SSA therapy (octreotide or lanreotide) participants were randomized to receive two placebo-matching telotristat etiprate tablets administered three times daily for 12 weeks in the double-blind treatment period, followed by a 36 week open-label extension period.

Treatment:

Drug: Placebo-matching telotristat etiprate

Telotristat Etiprate Open-Label Extension

Experimental group

Description:

Patients previously assigned to 250 mg or 500 mg three times daily of telotristat etiprate were administered two 250 mg telotristat etiprate tablets three times daily in a 36 week open-label extension (OLE) period. Patients previously assigned to placebo were administered one 250 mg telotristat etiprate tablet plus one placebo-matching tablet three times daily for one week, followed by two 250 mg telotristat etiprate tablets three times daily for 35 weeks.

Treatment:

Drug: Placebo-matching telotristat etiprate

Drug: Telotristat etiprate