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2021-05-13
2023-07-06
2025-07-06
18
NCT04634539
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
INTERVENTIONAL
Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-11-11 | N/A | 2025-04-01 |
2020-11-17 | N/A | 2025-04-03 |
2020-11-18 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Gemcitabine + Nab-paclitaxel + L-glutamine 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 wil | DRUG: Gemcitabine
DRUG: Nab-paclitaxel
DRUG: L-glutamine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Recommended phase II dose (RP2D) of combination gemcitabine, nab-paclitaxel, and L-glutamine in treatment-naive metastatic pancreatic cancer. | The number of dose-limiting toxicities (DLTs), defined as the rate of drug-related grade ≥3 adverse events (AEs) experienced within the first 4 weeks (1 cycle) of study treatment. The RP2D is defined as the dose level closest to the median of the posterior distribution of the maximum tolerated dose (MTD). The MTD is defined as the dose level such that the probability of DLT at the MTD is θ=0.33. | 4 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Describe the safety of gemcitabine, nab-paclitaxel and L-glutamine across all investigated dose levels in subjects with untreated advanced pancreatic cancer | Number of adverse events as assessed by NCI CTCAE version 5.0 | From first dose of study treatment until 30 days after the last dose of study treatment (up to approximately 12 months).. |
| 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. | Clinical activity of the combination including objective response rate (ORR), defined as proportion of patients with confirmed PR or CR, evaluated every 8 weeks (every 2 cycles ±1 week) according to the revised RECIST guidelines (version 1.1) | From screening/baseline until the last dose of study treatment (up to approximately 12 months). |
| 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. | Clinical activity of the combination including progression-free survival (PFS), defined as from baseline until date of progression or death due to any cause, evaluated every 8 weeks (every 2 cycles ±1 week) according to the revised RECIST guidelines (version 1.1). | From screening/baseline until the last dose of study treatment (up to approximately 12 months). |
| 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. | Clinical activity of the combination including overall survival (OS), defined as from baseline until date of death due to any cause, evaluated every 8 weeks (every 2 cycles ±1 week) according to the revised RECIST guidelines (version 1.1). | From screening/baseline until the last dose of study treatment (up to approximately 12 months). |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
