Phase 3
N=76
Telotristat Etiprate for Carcinoid Syndrome Therapy
Carcinoid Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02063659 ↗Enrolled (actual)
76
Serious AEs
18.2%
Results posted
Sep 2017
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period — 21; 25; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Telotristat etiprate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lexicon Pharmaceuticals
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period |
21; 25; 22 | — |
| PRIMARY Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels |
97.721; -33.164; -76.466 | < 0.001 sig |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period |
61 | — |
| SECONDARY Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks |
0.050; -0.452; -0.595 | — |
| SECONDARY Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points |
0.006; -0.196; -0.597 | — |
| SECONDARY Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points |
-0.333; -0.061; 0.114 | — |
| SECONDARY Change From Baseline in Abdominal Pain Averaged Across All Time-Points |
-0.063; -0.234; 0.025 | — |
| SECONDARY Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points |
-0.013; -0.065; 0.006 | — |
| SECONDARY Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline |
-0.906; -0.98 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02063659). 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.