Clinical trial · Interventional
Telotristat With Lutathera in Neuroendocrine Tumors
Study of Telotristat (Xermelo) in Combination With Luetetium Lu177 Dotatate (Lutathera) in Well-Differentiated Neuroendocrine Tumors
NCT04543955CI-TRIAL-00067564terminatedPhase 2Results postedClinicalTrials.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): Sponsor cancelled research
Summary
Brief summary (as posted)
This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telotristat (High-Dose) | Drug | — | UNRESOLVED |
| Telotristat (Low-Dose) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Low-Dose Telotristat
- description
- Participants in this group will receive 750mg Telotristat per day.
- interventionNames
- Drug: Telotristat (Low-Dose)
- type
- EXPERIMENTAL
- label
- Arm 2: High-Dose Telotristat
- description
- Participants in this group will receive 1500mg Telotristat per day.
- interventionNames
- Drug: Telotristat (High-Dose)
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 20 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior to study enrollment * Baseline CT scan or MRI with measurable progressive disease based on RECIST Criteria * Failure of at least one prior systemic cancer treatment for this diagnosis * Recovered from Adverse Events of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0 * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * normal organ and marrow function Exclusion Criteria: * Prior exposure to Lutetium Lu 177 Dotatate * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Telotristat or Lutetium Lu 177 Dotatate. * Presence of unstable angina or myocardial infarction * New York Heart Association (NYHA) Class III or IV heart failure * uncontrolled angina * history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities * Pregnant or lactating women * Women of childbearing potential or male patients of reproductive potential * Any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study
References
Publications (0)
Data not yet available
No reference posted for this study.