Trial · NCT03910387
Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer
NCT03910387, Phase 2, Completed, Emory University; results first posted 2025-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer. Trials, record NCT03910387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03910387
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer
- NCT number
- NCT03910387
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Emory University
- Conditions
Locally Advanced Unresectable Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8
- Interventions
- Gemcitabine, Nab-paclitaxel, Telotristat Ethyl
- First posted
- 2019-04-10
- Last updated
- 2025-12-16
- Results first posted
- 2025-12-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weight Stability | Baseline up to 3 months after study start | Weight stability will be documented as percent weight change at 3 months compared to baseline. |
| Secondary | Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Baseline up to 4 months after study start | The change will be summarized as mean and standard deviation. |
| Secondary | Mid Arm Circumference (MAC) Measured in cm | Up to 2 years after study start | Mid arm circumference (MAC) will be reviewed on cross sectional imaging and will be assessed with imaging guided measurements of the psoas and rectus abdominis muscle. |
| Secondary | Quality of Life (QOL) | Up to 2 years after study start | Quality of life (QOL) will be assessed by the Obesity Related Quality of Life (OWL-QOL)-17 questionnaire. \*Please note OC Measure was not collected. |
| Secondary | Blood Serotonin Levels | Up to 2 years after study start | Blood serotonin levels will be compared in the 2 groups. |
| Secondary | Response Rate (RR) | Up to 2 years after study start | Response rate (RR) will be assessed per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, in patients receiving telotristat ethyl (Group 1). |
| Secondary | Median Overall Survival (MOS) | Up to 2 years after study start | Median overall survival (MOS) will be measured using the Kaplan-Meier method. |
| Secondary | Duration of Response | Up to 2 years after study start | Duration of response will be estimated from time of documentation of response to time of progression and will be evaluated by computed tomography/magnetic resonance imaging scans of the organ(s) with the target lesion(s) based on RECIST criteria. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Weight Stability | Baseline up to 3 months after study start | Percent weight change | MEAN | |
| SECONDARY | Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Baseline up to 4 months after study start | Milligrams | MEAN | |
| SECONDARY | Mid Arm Circumference (MAC) Measured in cm | Up to 2 years after study start | This OC was not collected at the following timepoints, and a protocol amendment did not occur.~Cycle 7 Day 1, Group 2 Cycle 8 Day 1, Group 2 Cycle 10 Day 1, Group 1 Cycle 11 Day 1, Group 1 Cycle 12 Day 1, Group 1 Cycle 13 Day 1, Group 1 Cycle 14 Day 1, Group 1 Cycle 15 Day 1, Group 1 \& 2 Cycle 17 Day 1, Group 1 \&2 Cycle 18 Day 1 Group 2 Cycle 19 Day 1, Group 2 Cycle 22 Day 1, Group 2 Cycle 23 Day 1, Group 2 | cm | MEAN |
| SECONDARY | Quality of Life (QOL) | Up to 2 years after study start | |||
| SECONDARY | Blood Serotonin Levels | Up to 2 years after study start | ng/mL | MEAN | |
| SECONDARY | Response Rate (RR) | Up to 2 years after study start | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Overall Survival (MOS) | Up to 2 years after study start | Days | MEDIAN | |
| SECONDARY | Duration of Response | Up to 2 years after study start | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group59
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weight Stability | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | -1.98 | Standard Deviation 6.87 | Percent weight change | |
| Weight Stability | Group 2 (gemcitabine/nab-paclitaxel) | -5.58 | Standard Deviation 5.89 | Percent weight change | |
| Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | Screening | 3 | Standard Deviation 261.67 | Milligrams |
| Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Group 2 (gemcitabine/nab-paclitaxel) | Screening | 4 | Standard Deviation 46.25 | Milligrams |
| Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | Cycle 1 Day 1 (Treatment day 0) | 8 | Standard Deviation 232.38 | Milligrams |
| Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Group 2 (gemcitabine/nab-paclitaxel) | Cycle 1 Day 1 (Treatment day 0) | 3 | Standard Deviation 44.87 | Milligrams |
| Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | Cycle 2 Day 1 (Treatment day 28) | 8 | Standard Deviation 58.63 | Milligrams |
| Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Group 2 (gemcitabine/nab-paclitaxel) | Cycle 2 Day 1 (Treatment day 28) | 2 | Standard Deviation 144.00 | Milligrams |
| Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | Cycle 3 Day 1 (Treatment day 56) | 7 | Standard Deviation 119.10 | Milligrams |
| Change in 24-hr Urine 5-hydroxyindoleacetic Acid (5-HIAA) Levels | Group 2 (gemcitabine/nab-paclitaxel) | Cycle 3 Day 1 (Treatment day 56) | 1 | Standard Deviation 273.00 | Milligrams |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 14 | |
| Overall Study | STARTED | Group 2 (gemcitabine/nab-paclitaxel) | 9 | |
| Overall Study | COMPLETED | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 14 | |
| Overall Study | COMPLETED | Group 2 (gemcitabine/nab-paclitaxel) | 9 | |
| Overall Study | NOT COMPLETED | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 0 | |
| Overall Study | NOT COMPLETED | Group 2 (gemcitabine/nab-paclitaxel) | 0 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 3 | 14 | 24 |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Group 2 (gemcitabine/nab-paclitaxel) | 3 | 8 | 3 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 8 | 14 | 17 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Group 2 (gemcitabine/nab-paclitaxel) | 1 | 8 | 1 |
| other | General disorders and administration site conditions | General disorders | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 9 | 14 | 20 |
| other | General disorders and administration site conditions | General disorders | Group 2 (gemcitabine/nab-paclitaxel) | 1 | 8 | 11 |
| other | Infections and infestations | Infections and infestations | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 0 | 14 | 0 |
| other | Infections and infestations | Infections and infestations | Group 2 (gemcitabine/nab-paclitaxel) | 1 | 8 | 2 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 1 | 14 | 1 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Group 2 (gemcitabine/nab-paclitaxel) | 0 | 8 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 9 | 14 |
| Total, all-cause mortality | Group 2 (gemcitabine/nab-paclitaxel) | 6 | 8 |
| Total, other adverse events | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 13 | 14 |
| Total, other adverse events | Group 2 (gemcitabine/nab-paclitaxel) | 3 | 8 |
| Total, serious adverse events | Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | 2 | 14 |
| Total, serious adverse events | Group 2 (gemcitabine/nab-paclitaxel) | 0 | 8 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) vs Group 2 (gemcitabine/nab-paclitaxel): Response Rate (RR) | Trial comparisons |
| Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) vs Group 2 (gemcitabine/nab-paclitaxel): deaths from any cause | Trial comparisons |
| Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) vs Group 2 (gemcitabine/nab-paclitaxel): serious adverse events | Trial comparisons |
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/NCT03910387
GET https://conductscience.org/api/trials/v1/NCT03910387/results?page=2