Pancreatic CancerPhase 2NCT07864571
Trial of First-line Gemcitabine and Nab-paclitaxel With or Without L-glutamine in Advanced Pancreatic Cancer
A Phase 2 study testing Gemcitabine (1000 mg/m2), Nab-paclitaxel and L-glutamine in people with Pancreatic Cancer, run by Jun Gong, MD at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine (1000 mg/m2), 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
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 ductal adenocarcinoma (PDAC, new diagnosis or recurrent, where recurrent tumor does not need to be histologically-confirmed) referred to Cedars-Sinai Medical Center (CSMC), Samuel Oschin Comprehensive Cancer Institute (SOCCI), USC, or UC Irvine 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
- ECOG performance status ≤2 or Karnofsky performance status ≥60%
- Demonstrate adequate organ and marrow function
- Have measurable disease based on RECIST 1.1
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 14 days prior to receiving the first dose of study medication for eligibility verification. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: Negative urine or serum pregnancy test is also conducted within 72 hours prior to C1D1 for study procedures and should not preclude eligibility verification, but if screening pregnancy test is done within 72 hours of C1D1, it is not required to be repeated.
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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 provide baseline tissue, stool, and blood samples under prespecified conditions (i.e., fasted, morning blood collections)
- Must be willing to provide repeat stool and blood samples after 1-week lead-in (±3 day window) and optional post-progression tumor biopsy
- 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 treatment was completed ≥6 months prior to recurrence).
- 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.
- Patients on strong CYP2C8 or CYP3A4 inhibitors or inducers within 1 week prior to starting nab-paclitaxel (Appendix X).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Jun Gong, MD, 310-423-5776, jun.gong@csmc.edu
About this study
Official title: Phase II Randomized Clinical Trial of First-line Gemcitabine and Nab-paclitaxel With or Without L-glutamine in Advanced Pancreatic Cancer (GlutaPanc II)
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine (1000 mg/m2), Nab-paclitaxel, L-glutamine
- Keywords
- gemcitabine, nabpaclitaxel, advanced pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine (1000 mg/m2)Drug
1000 mg/m^2 IV on D1, 8, and 15 of cycle
Nab-paclitaxelDrug
125 mg/m^2 IV on D1, 8, and 15 of cycle
L-glutamineDrug
0.3 g/kg oral BID
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | L-glutamine, gemcitabine, and nab-paclitaxel Receives: Drug: Gemcitabine (1000 mg/m2); Drug: Nab-paclitaxel; Drug: L-glutamine |
| Control Group | Active comparator | Gemcitabine and nab-paclitaxel Receives: Drug: Gemcitabine (1000 mg/m2); Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
To determine the clinical efficacy of L-glutamine supplementation with gemcitabine and nab-paclitaxel to gemcitabine and nab-paclitaxel alone in the first-line treatment of advanced pancreatic cancer
Measured: 2 years post End of Treatment
Secondary outcomes (6)
Progression Free Survival (PFS)
Measured: 2 years post End of Treatment
Objective Response Rate (ORR)
Measured: 2 years post End of Treatment
Safety based on NCI CTCAE Version 5.0
Measured: 2 years
Weight change
Weight gain, as measured by the change in body weight from baseline to 12 weeks of study treatment
Measured: Up to 12 weeks
Weight stability
Weight stability, as defined by weight change less than 0.1 kg/baseline body mass index (BMI)-unit) at 12 weeks of study treatment
Measured: up to 12 weeks
Body composition
Body composition assessment, as measured by the difference between baseline skeletal muscle index (SMI) or adipose tissue index (ATI) and the SMI or ATI calculated at first follow-up CT scan
Measured: at first follow-up CT scan, around 8 weeks post cycle 1 day 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Gong, MD
- Sponsor type
- University, hospital or other
- 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
- NCT07864571
- Sponsor's protocol ID
- IIT2026-20-Gong
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Clinical Trial of First-line Gemcitabine and Nab-paclitaxel With or Without L-glutamine in Advanced Pancreatic Cancer (GlutaPanc II)
- ClinicalTrials.gov ID
- NCT07864571
- Acronym / sponsor ID
- IIT2026-20-Gong
- Conditions
- Pancreatic Cancer
- Keywords
- gemcitabine, nabpaclitaxel, advanced pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jun Gong, MDUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Oct 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Gemcitabine (1000 mg/m2), Drug: Nab-paclitaxel, Drug: L-glutamineL-glutamine, gemcitabine, and nab-paclitaxel |
| Control Group | Active comparator | Drug: Gemcitabine (1000 mg/m2), Drug: Nab-paclitaxelGemcitabine and nab-paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Advanced or unresectable, histologically confirmed pancreatic ductal adenocarcinoma (PDAC, new diagnosis or recurrent, where recurrent tumor does not need to be histologically-confirmed) referred to Cedars-Sinai Medical Center (CSMC), Samuel Oschin Comprehensive Cancer Institute (SOCCI), USC, or UC Irvine 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
- ECOG performance status ≤2 or Karnofsky performance status ≥60%
- Demonstrate adequate organ and marrow function
- Have measurable disease based on RECIST 1.1
Key exclusion criteria (11 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 treatment was completed ≥6 months prior to recurrence).
- 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 |
|---|---|---|
| Gemcitabine (1000 mg/m2)1000 mg/m^2 IV on D1, 8, and 15 of cycle | Drug | Control Group, Experimental Group |
| Nab-paclitaxel125 mg/m^2 IV on D1, 8, and 15 of cycle | Drug | Control Group, Experimental Group |
| L-glutamine0.3 g/kg oral BID | Drug | Experimental Group |
Primary outcome
Overall Survival (OS)
Time frame: 2 years post End of Treatment
To determine the clinical efficacy of L-glutamine supplementation with gemcitabine and nab-paclitaxel to gemcitabine and nab-paclitaxel alone in the first-line treatment of advanced pancreatic cancer
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: 2 years post End of Treatment
Objective Response Rate (ORR)
Time frame: 2 years post End of Treatment
Safety based on NCI CTCAE Version 5.0
Time frame: 2 years
Weight change
Time frame: Up to 12 weeks
Weight stability
Time frame: up to 12 weeks
Body composition
Time frame: at first follow-up CT scan, around 8 weeks post cycle 1 day 1 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Jun Gong, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine (1000 mg/m2), Nab-paclitaxel and L-glutamine in people with Pancreatic Cancer, run by Jun Gong, MD at 1 site 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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Gong, MD (310-423-5776, jun.gong@csmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 2 years post End of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.