Phase 3
Completed N=135
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Carcinoid Syndrome
Source: ClinicalTrials.gov NCT01677910 ↗
Enrolled (actual)
135
Serious AEs
23.6%
Results posted
Sep 2017
Primary outcomePrimary: Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks — -0.623; -1.433; -1.455 counts/day — p=< 0.001
◆ Published Evidence
Established
32citations · ~4 / year
Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR.
Summary
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.
Linked Publications (5)
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Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR.
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Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome.
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Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome.
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Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST.
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A Budget Impact Model of the Addition of Telotristat Ethyl Treatment to the Standard of Care in Patients with Uncontrolled Carcinoid Syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks |
-0.623; -1.433; -1.455 | < 0.001 sig |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period |
39; 37; 42 | — |
| PRIMARY Number of Participants With TEAEs in the Open-Label Extension Period |
110 | — |
| SECONDARY Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels |
11.350; -40.134; -57.519 | — |
| SECONDARY Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points |
-0.164; -0.296; -0.525 | — |
| SECONDARY Change From Baseline in Abdominal Pain Averaged Across All Time-Points |
-0.226; -0.489; -0.333 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01677910) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.