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Anti-metabolites

L-glutamine + Chemotherapy for Pancreatic Cancer

Phase 1
Waitlist Available
Research Sponsored by Jun Gong, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 or Karnofsky performance status ≥60%
Advanced or unresectable, histologically confirmed pancreatic cancer referred to Cedars-Sinai Medical Center (CSMC), Samuel Oschin Comprehensive Cancer Institute (SOCCI) for first-line chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening/baseline until the last dose of study treatment (up to approximately 12 months).
Awards & highlights

Study Summary

This trial will study the effects of adding L-glutamine to standard chemo for advanced pancreatic cancer. 16 patients will be enrolled at Cedars-Sinai.

Who is the study for?
Adults with advanced pancreatic cancer who haven't had chemotherapy for metastatic disease can join. They must have good organ function, not be pregnant or breastfeeding, agree to use birth control, and be able to follow the study plan. People with severe pre-existing neuropathy, other active cancers, or conditions that could affect the study's outcome cannot participate.Check my eligibility
What is being tested?
The trial is testing a combination of gemcitabine and nab-paclitaxel with L-glutamine in patients at Cedars-Sinai Medical Center. It aims to find the safest dose of L-glutamine and see if it boosts the effectiveness of standard chemotherapy in treating advanced pancreatic cancer.See study design
What are the potential side effects?
Possible side effects include reactions from gemcitabine and nab-paclitaxel such as nausea, fatigue, hair loss, blood cell count changes leading to infection risk increase or bleeding problems. L-glutamine's risks are being studied but may include digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My pancreatic cancer is advanced or cannot be surgically removed and I am referred to CSMC/SOCCI for first chemotherapy.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening/baseline until the last dose of study treatment (up to approximately 12 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening/baseline until the last dose of study treatment (up to approximately 12 months). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase II dose (RP2D) of combination gemcitabine, nab-paclitaxel, and L-glutamine in treatment-naive metastatic pancreatic cancer.
Secondary outcome measures
Describe any preliminary evidence of antitumor activity of the combination by assessment of objective response rate as determined by RECIST 1.1 criteria in patients with measurable disease.
Describe any preliminary evidence of antitumor activity of the combination by assessment of overall survival as determined by RECIST 1.1 criteria in patients with measurable disease.
Describe any preliminary evidence of antitumor activity of the combination by assessment of progression-free survival as determined by RECIST 1.1 criteria in patients with measurable disease.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gemcitabine + Nab-paclitaxel + L-glutamineExperimental Treatment3 Interventions
For the dose-finding portion of this study, all subjects will receive a combination of L-glutamine, gemcitabine, and nab-paclitaxel which will be preceded by a 1-week (+/- 1 day) administration of L-glutamine. This 1-week administration of L-glutamine will facilitate measurement of baseline and post-glutamine monotherapy plasma metabolite levels prior to addition of gemcitabine and nab-paclitaxel. The combination therapy will be administered over 28-day cycles during the treatment period until disease progression, treatment intolerance, or withdrawal from the study. Patients are expected to be on treatment for 12 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
L-glutamine
2019
Completed Phase 4
~330

Find a Location

Who is running the clinical trial?

Jun Gong, MDLead Sponsor
Emmaus Medical, Inc.Industry Sponsor
7 Previous Clinical Trials
364 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04634539 — Phase 1
Pancreatic Cancer Research Study Groups: Gemcitabine + Nab-paclitaxel + L-glutamine
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04634539 — Phase 1
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634539 — Phase 1
~4 spots leftby Jun 2025
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