Advanced Pancreatic AdenocarcinomaPhase 1NCT04634539
Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer
A Phase 1 study testing Gemcitabine, Nab-paclitaxel and L-glutamine in people with Advanced Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Jun Gong, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Adenocarcinoma, Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Gemcitabine, Nab-paclitaxel and L-glutamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2021to 17 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or unresectable, histologically confirmed pancreatic cancer (new diagnosis or recurrent) referred to Cedars-Sinai Medical Center (CSMC), Samuel Oschin Comprehensive Cancer Institute (SOCCI) for first-line chemotherapy. Prior neoadjuvant or adjuvant chemotherapy and/or chemoradiation is allowed but must have been completed >6 months prior to recurrence.
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 or Karnofsky performance status ≥60%
- Demonstrate adequate organ and marrow function (within 14 days of study treatment initiation)
- Have measurable disease based on RECIST 1.1
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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- Female subjects of childbearing potential should be willing to use adequate methods of birth control (hormonal or barrier method of birth control) or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Willingness to undergo serial peripheral blood draws and provide stool samples during predefined study timepoints and under prespecified conditions (i.e., fasted, morning blood collections).
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Has previously received chemotherapy for metastatic disease (treatment with neoadjuvant or adjuvant therapy is allowed so long as progression occurred ≥6 months).
- Has pre-existing grade ≥3 neuropathy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Has a known hypersensitivity to any components of the study drugs.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
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- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has any gastrointestinal disorder (e.g., bowel obstruction) or neurologic condition (e.g., oropharyngeal dysphagia) that may result in impairment of oral intake and/or absorption of study drug in the opinion of the treating investigator.
- Is currently receiving any parenteral nutrition or enteral (tube) feeding or is planning to use any other nutritional supplement during the study period.
- Patients on strong CYP2C8 or CYP3A4 inhibitors or inducers within 1 week prior to starting nab-paclitaxel
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tower Hematology Oncology Medical Group (THO)
Beverly Hills, California, 90211
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: IIT2020-02-Gong-GlutaPanc: Phase I Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer (GlutaPanc)
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.
- Being tested
- Gemcitabine, Nab-paclitaxel, L-glutamine
- Keywords
- gemcitabine, nab-paclitaxel, L-glutamine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
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.
Nab-paclitaxelDrug
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.
L-glutamineDrug
Also called Endari
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.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Nab-paclitaxel + L-glutamine | Experimental | 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. Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: L-glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (4)
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
Measured: 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)
Measured: 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).
Measured: 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).
Measured: From screening/baseline until the last dose of study treatment (up to approximately 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start13 May 2021
- Primary completion6 Jul 2023
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Gong, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Emmaus Medical, Inc.
- Responsible party
- Sponsor-investigator, Jun Gong, MD, Cedars-Sinai Medical Center
- Investigators
- Jun Gong, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634539
- Sponsor's protocol ID
- IIT2020-02-Gong-GLUTAPANC
- Status last verified
- Aug 2025
- First submitted
- 11 Nov 2020
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gong J, Muranaka H, Choi SY, Tighiouart M, Bhute S, Aja ER, Jacobs JP, Stotland A, Van Eyk J, Elmadbouh OHM, Edderkaoui M, Tanaka S, Furuya H, Osipov A, Lorber J, Billet S, Morris A, Ten Hoeve-Scott J, Graeber T, Pandol SJ, Hendifar A, Bhowmick NA. L-Glutamine in combination with first-line gemcitabine and nab-paclitaxel in advanced pancreatic ductal adenocarcinoma: an open-label, single-arm, phase 1 GlutaPanc trial. Nat Cancer. 2026 Aug 31. doi: 10.1038/s43018-026-01225-z. Online ahead of print.
PubMed 42675216
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2020-02-Gong-GlutaPanc: Phase I Trial of First-line L-glutamine With Gemcitabine and Nab-paclitaxel in Advanced Pancreatic Cancer (GlutaPanc)
- ClinicalTrials.gov ID
- NCT04634539
- Acronym / sponsor ID
- IIT2020-02-Gong-GLUTAPANC
- Keywords
- gemcitabine, nab-paclitaxel, L-glutamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jun Gong, MDUniversity, hospital or other
- Collaborators
- Emmaus Medical, Inc.
- Study start
- 13 May 2021 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Nab-paclitaxel + L-glutamine | Experimental | Drug: Gemcitabine, Drug: Nab-paclitaxel, Drug: L-glutamineFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Advanced or unresectable, histologically confirmed pancreatic cancer (new diagnosis or recurrent) referred to Cedars-Sinai Medical Center (CSMC), Samuel Oschin Comprehensive Cancer Institute (SOCCI) for first-line chemotherapy. Prior neoadjuvant or adjuvant chemotherapy and/or chemoradiation is allowed but must have been completed >6 months prior to recurrence.
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 or Karnofsky performance status ≥60%
- Demonstrate adequate organ and marrow function (within 14 days of study treatment initiation)
- Have measurable disease based on RECIST 1.1
Key exclusion criteria (12 listed)
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Has previously received chemotherapy for metastatic disease (treatment with neoadjuvant or adjuvant therapy is allowed so long as progression occurred ≥6 months).
- Has pre-existing grade ≥3 neuropathy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Has a known hypersensitivity to any components of the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineGemcitabine 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 | Gemcitabine + Nab-paclitaxel + L-glutamine |
| Nab-paclitaxelNab-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 | Gemcitabine + Nab-paclitaxel + L-glutamine |
| L-glutamineAlso: EndariThe 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. | Drug | Gemcitabine + Nab-paclitaxel + L-glutamine |
Primary outcome
Recommended phase II dose (RP2D) of combination gemcitabine, nab-paclitaxel, and L-glutamine in treatment-naive metastatic pancreatic cancer.
Time frame: 4 weeks
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 secondary outcomes
Describe the safety of gemcitabine, nab-paclitaxel and L-glutamine across all investigated dose levels in subjects with untreated advanced pancreatic cancer
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From screening/baseline until the last dose of study treatment (up to approximately 12 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 42675216Gong J, Muranaka H, Choi SY, Tighiouart M, Bhute S, Aja ER, Jacobs JP, Stotland A, Van Eyk J, Elmadbouh OHM, Edderkaoui M, Tanaka S, Furuya H, Osipov A, Lorber J, Billet S, Morris A, Ten Hoeve-Scott J, Graeber T, Pandol SJ, Hendifar A, Bhowmick NA. L-Glutamine in combination with first-line gemcitabine and nab-paclitaxel in advanced pancreatic ductal adenocarcinoma: an open-label, single-arm, phase 1 GlutaPanc trial. Nat Cancer. 2026 Aug 31. doi: 10.1038/s43018-026-01225-z. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Gong, MD principal investigator
Cedars-Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine, Nab-paclitaxel and L-glutamine in people with Advanced Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Jun Gong, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended phase II dose (RP2D) of combination gemcitabine, nab-paclitaxel, and L-glutamine in treatment-naive metastatic pancreatic cancer. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04634539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.