Trial · NCT04543955
Telotristat With Lutathera in Neuroendocrine Tumors
NCT04543955, Phase 2, Terminated, Lowell Anthony, MD; results first posted 2023-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Telotristat With Lutathera in Neuroendocrine Tumors. Trials, record NCT04543955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04543955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telotristat With Lutathera in Neuroendocrine Tumors
- NCT number
- NCT04543955
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Lowell Anthony, MD
- Conditions
- Neuroendocrine Tumors
- Interventions
- Telotristat (Low-Dose), Telotristat (High-Dose)
- First posted
- 2020-09-10
- Last updated
- 2023-06-27
- Results first posted
- 2023-06-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 20 months | Progression-free survival at 20 months. |
| Secondary | Overall Response Rate (ORR) | 6 and 12 months | Overall response rate using RECIST v1.1 at 6 and 12 months after therapy |
| Secondary | Median Progression-Free Survival (PFS) | 36 month | Median progression-free survival. |
| Secondary | Urinary 5-HIAA | Baseline and 12 months | Levels of urinary 5-Hydroxyindoleacetic acid (5-HIAA) will be measured at baseline and 12 months. |
| Secondary | Quality of Life (QLQ-C30) | 20 month | The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients.It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items.Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. |
| Secondary | Quality of Life (QLQ-GI.NET21) | 20 month | The Quality of Life GI Neuroendocrine Tumor survey (QLQ-GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organised into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | 20 months | One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented. | ||
| SECONDARY | Overall Response Rate (ORR) | 6 and 12 months | One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented. | ||
| SECONDARY | Median Progression-Free Survival (PFS) | 36 month | One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented. | ||
| SECONDARY | Urinary 5-HIAA | Baseline and 12 months | One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented. | ||
| SECONDARY | Quality of Life (QLQ-C30) | 20 month | One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented. | ||
| SECONDARY | Quality of Life (QLQ-GI.NET21) | 20 month | One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Low-Dose Telotristat | 1 | |
| Overall Study | STARTED | Arm 2: High-Dose Telotristat | 0 | |
| Overall Study | COMPLETED | Arm 1: Low-Dose Telotristat | 0 | |
| Overall Study | COMPLETED | Arm 2: High-Dose Telotristat | 0 | |
| Overall Study | NOT COMPLETED | Arm 1: Low-Dose Telotristat | 1 | |
| Overall Study | NOT COMPLETED | Arm 2: High-Dose Telotristat | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Low-Dose Telotristat | 0 | 0 |
| Total, all-cause mortality | Arm 2: High-Dose Telotristat | 0 | 0 |
| Total, other adverse events | Arm 1: Low-Dose Telotristat | 0 | 0 |
| Total, other adverse events | Arm 2: High-Dose Telotristat | 0 | 0 |
| Total, serious adverse events | Arm 1: Low-Dose Telotristat | 0 | 0 |
| Total, serious adverse events | Arm 2: High-Dose Telotristat | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04543955
GET https://conductscience.org/api/trials/v1/NCT04543955/registered