drugset
drugset / Trial / NCT04634539

Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer

NCT04634539 ↗

Phase 1 Completed 18 enrolled Jun Gong, MD Emmaus Medical, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

This study will enroll a total of 16 patients with advanced pancreatic cancer at Cedars-Sinai Medical Center. All subjects will receive combination therapy of gemcitabine, nab-paclitaxel, and L-glutamine. The study investigates what the appropriate dosage of L-glutamine is so that there is the lowest risk of side effects, and whether the supplement will make standard chemotherapy of gemcitabine and nab-paclitaxel more effective in treating advanced pancreatic cancer.

Timeline

Start
2021-05-13
Primary completion
2023-07-06
Completion
2025-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 600 mg/m2 Intravenous
Subject Gemcitabine Small molecule 800 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Glutamine Other / unclassified 0.1 g/kg Oral
Subject Glutamine Other / unclassified 0.2 g/kg Oral
Subject Glutamine Other / unclassified 0.3 g/kg Oral
Subject Paclitaxel Small molecule 75 mg/m2 Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous

Indications

pancreatic ductal adenocarcinoma