Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03910387 | Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer | PHASE2 | COMPLETED | 23 | — | — | Apr 17, 2019 | Jun 29, 2022 | Dec 16, 2025 | 3 | United States |
Weight stability will be documented as percent weight change at 3 months compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Group 1 (gemcitabine/nab-paclitaxel and telotristat ethyl) | EXPERIMENTAL | Patients receive gemcitabine/nab-paclitaxel combination chemotherapy on days 1, 8 and 15, and telotristat ethyl PO QD, BID, or TID on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Group 2 (gemcitabine/nab-paclitaxel) | ACTIVE_COMPARATOR | Patients receive gemcitabine/nab-paclitaxel chemotherapy (at the discretion of the investigator) on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Given gemcitabine/nab-paclitaxel combination therapy |
| Nab-paclitaxel | DRUG | Given gemcitabine/nab-paclitaxel combination therapy |
| Telotristat Ethyl | DRUG | Given PO |
Inclusion Criteria: * GROUP 1 (Telotristat ethyl treatment group): Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separat...