NCT04634539

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

IIT2020-02-Gong-GlutaPanc: Phase I Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer (GlutaPanc)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Jun Gong, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine will be administered at 600, 800, or 1000 mg/m2 intravenous (IV) infusion over 30 minutes on days 1, 8, and 15 (every 28-day cycles) during the treatment period. Gemcitabine will be administered immediately after the infusion of nab-paclitaxel. Pre-medication with may be administered per institutional standard practice at the investigator's discretion with gemcitabine.
DRUG	Nab-paclitaxel	Nab-paclitaxel will be administered at 75, 100, or 125 mg/m2 intravenous (IV) infusion over 30 minutes on days 1, 8, and 15 (every 28-day cycles) during the treatment period. Nab-paclitaxel will be given first, before infusion of gemcitabine. Pre-medication for nab-paclitaxel may be administered per institutional standard practice at investigator's discretion.
DRUG	L-glutamine	The dose levels of L-glutamine in this study will be 0.1, 0.2, and 0.3 g/kg oral twice daily (rounded to nearest 5 g with an upper limit of 15 g twice daily (30 g/day) for any dose level) taken at the same time each day during the treatment period. L-glutamine will be administered for 1 week (+/-1 day) prior to addition of gemcitabine/nab-paclitaxel. Each dose of L-glutamine should be mixed immediately before ingestion with 8 oz. (240 mL) of a cold or room temperature beverage, such as water, milk or apple juice, or 4 oz. (120 mL) to 6 oz. (177 mL) of food such as applesauce or yogurt. L-glutamine is formulated in 5 gram packets as a white crystalline powder in paper-foil-plastic laminate. Complete dissolution is not required prior to administration.

Timeline

• Start date: 2021-05-13
• Primary completion: 2023-07-06
• Completion: 2025-06-17
• First posted: 2020-11-18
• Last updated: 2025-08-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study