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Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer

NCT03910387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-12-16

Study results available
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Summary

This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.

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

DRUG

Gemcitabine

Given gemcitabine/nab-paclitaxel combination therapy

DRUG

Nab-paclitaxel

Given gemcitabine/nab-paclitaxel combination therapy

DRUG

Telotristat Ethyl

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Lexicon Pharmaceuticals

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Gehan Botrus, MD, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2022-06-29
Completion
2022-06-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03910387 on ClinicalTrials.gov