Trial of First-line Gemcitabine and Nab-paclitaxel With or Without L-glutamine in Advanced Pancreatic Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor: Jun Gong, MD
Study ID: NCT07864571
Phase: PHASE2
Status: Not Yet Recruiting

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Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Gemcitabine (1000 mg/m2) — DRUG
1000 mg/m\^2 IV on D1, 8, and 15 of cycle
Nab-paclitaxel — DRUG
125 mg/m\^2 IV on D1, 8, and 15 of cycle
L-glutamine — DRUG
0.3 g/kg oral BID

Study Details

This is a multi-institution, open-label, two-arm, prospective randomized controlled phase I trial with the purpose to investigate the clinical efficacy of combination gemcitabine, nab-paclitaxel, and L-glutamine compared to gemcitabine and nab-paclitaxel alone in treatment-naïve, unresectable or metastatic pancreatic cancer. This study hypothesizes that combining L-glutamine with gemcitabine and nab-paclitaxel represents a superior therapeutic strategy over gemcitabine and nab-paclitaxel alone in the first-line treatment of advanced PDAC based on the positive results of the phase I GlutaPanc trial that demonstrated the feasibility and preliminary efficacy of combining glutamine supplementation with gemcitabine and nab-paclitaxel in the first-line treatment of advanced PDAC. This study also plans to characterize the safety and secondary endpoints of efficacy (ORR and PFS) of the combination in this cohort. Additionally, the study will characterize the anti-cachexia effects of the study combination compared to control through standard measures such as weight gain, weight stability, and body composition assessments. Lastly, this study will conduct correlative studies on study treatment impact on tumor metabolism, the gut microbiome composition and bacterial metabolism, the plasma and fecal metabolome, and inflammatory signaling, relative to control, to identify potential biomarkers to guide selection of candidates ideal for L-glutamine-based combination therapy.