Clinical trial · Observational
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
IIT2018-26 -Hendifar-NETCx: A Descriptive, Multicenter, Single-arm, Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
NCT04034745CI-TRIAL-00049179withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of funding
Summary
Brief summary (as posted)
This single arm study will evaluate whether Xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (NET) patients with a history of carcinoid syndrome.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia; Cancer | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| telotristat ethyl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Standard of Care telotristat ethyl (Xermelo) Treatment
- description
- Treatment of telotristat ethyl (Xermelo) with DXA scans and bionutritional assessments (24-hour food recall and taste/smell alteration) conducted 3x during telotristat ethyl treatment.
- interventionNames
- Drug: telotristat ethyl
Primary outcomes (1)
- measure
- Mean change in lean body mass (measured using DXA Scan) from baseline and after 13 weeks of treatment.
- timeFrame
- From baseline to 13 weeks after treatment
Secondary outcomes (9)
- measure
- Mean change in patient reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) from baseline up to 3 years post treatment.
- timeFrame
- From baseline to 3 years post treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Histopathologically confirmed diagnosis of a metastatic NET. * Documented history of carcinoid syndrome. * Currently receiving treatment with long-acting SSAs with a plan to initiate therapy with telotristat-ethyl as per standard of care. * ECOG performance status 0-1 and/or Karnofsky \>60%. * Greater than or equal to 3 month life expectancy. * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Patients experiencing more than 12 watery BMs per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection. * History of short bowel syndrome. * Clinically important baseline elevation in liver function tests. * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Malignant ascites requiring paracenteses. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Bowel obstruction, partial, or total. * Pregnancy * Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment, other than diarrhea
References
Publications (0)
Data not yet available
No reference posted for this study.