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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening/baseline until the last dose of study treatment (up to approximately 12 months).

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

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are benefiting from this clinical experiment?

"Affirmative. Details on clinicaltrials.gov reveal that this medical trial is presently enrolling patients; it was initially published on May 13th 2021 and has since been updated in August of 2022. This investigation requires 16 volunteers at two distinct centres."

Answered by AI

Could you walk me through the existing research regarding L-glutamine?

"Currently, 1118 studies are underway exploring the efficacy of L-glutamine. Out of those trials, 322 have reached Phase 3 testing. The vast majority of these clinical operations are based in Shanghai; however there is a total 59459 sites running tests with this medication globally."

Answered by AI

What medical conditions can be aided by the use of L-glutamine?

"L-glutamine is regularly prescribed to patients undergoing post-anthracycline adjuvant treatments. Moreover, this medication can be beneficial for treating metastatic bladder cancer, neoplasm metastasis and locally advanced non-small cell lung cancer."

Answered by AI

Is there still an opportunity to partake in this experiment?

"Affirmative; according to data on clinicaltrials.gov, the trial is seeking participants at this time. Commencing initially on May 13th 2021, it was most recently modified on August 31st 2022 and seeks 16 patients from two distinct sites."

Answered by AI

What potential risks remain associated with the ingestion of L-glutamine?

"As L-Glutamine is currently in its first phase of clinical trials, the safety score determined by Power was 1 due to a lack of evidence regarding efficacy and protection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Jun Gong, MD 2021. "Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04634539.