Metastatic Pancreatic Ductal AdenocarcinomaPhase 1/2RAG-MPDACNCT07475234
Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1/2 study testing Rimegepant plus Nab-Paclitaxel and Gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Xiuchao Wang.
Trial summary
This study aims to evaluate the efficacy and safety of Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Rimegepant plus Nab-Paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2028
- Phase
- Phase 1/2
- 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
- The patient has good compliance, understands the study procedures, and has signed a written informed consent form.
- Age ≥ 18 years.
- Pathologically or cytologically confirmed pancreatic cancer, with imaging or pathological findings indicating unresectable pancreatic cancer with distant metastasis.
- Patients who have not received any prior treatment for pancreatic cancer (including radiotherapy, chemotherapy, or experimental therapy), except for surgical resection.
- If the patient has received neoadjuvant/adjuvant chemotherapy, the regimen must not contain AG, and the interval from the last administration to the diagnosis of recurrence must be >6 months, with no delayed toxicities.
- The patient has at least one measurable lesion according to the RECIST 1.1 criteria.
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- ECOG performance status 0-1.
- Expected survival >3 months.
- Adequate organ function, defined as meeting the following criteria (blood tests to be completed within 14 days prior to enrollment):
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
- Hemoglobin ≥90 g/dL
- Platelet count (PLT) ≥100 × 10⁹/L
- Total bilirubin <1.5 × upper limit of normal (ULN)
- Liver transaminases (AST \& ALT) <2.5 × ULN; for patients with liver metastases, AST/ALT ≤5 × ULN
- Serum creatinine ≤1 × ULN, or creatinine clearance ≥50 mL/min if serum creatinine >1 × ULN
- The patient has an adequate nutritional status, defined as BMI >18.5 kg/m².
- Female patients who are not pregnant or breastfeeding; sexually active men and women of childbearing potential must use effective contraception during the study and for 6 months after treatment completion.
- No contraindications to remimazolam or AG chemotherapy agents.
Who cannot join
- Patients with a history of other malignancies within the past 5 years, except for cured in situ carcinoma or basal cell carcinoma of the skin.
- Patients diagnosed with pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.
- Patients with refractory pleural effusion or ascites.
- Patients with known brain or meningeal metastases.
- Patients who used strong CYP3A4 inducers within 3 weeks prior to the first study drug administration, or strong CYP3A4/UGT1A1 inhibitors within 3 weeks prior to the first study drug administration.
- Patients who underwent major organ surgery (excluding needle biopsy, central venous catheter insertion, port catheterization, biliary obstruction stenting, percutaneous transhepatic biliary drainage, and cholecystostomy) within 4 weeks prior to the first dose of study drug, or who plan to undergo elective surgery.
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- Patients with known dihydropyrimidine dehydrogenase deficiency or low activity.
- Patients with active infection, including HIV infection, or chronic HBV/HCV in the active phase (HBV DNA ≥10⁴ copies/mL or ≥2000 IU/mL; patients must receive antiviral therapy first, and can only be enrolled when HBV DNA <10⁴ copies/mL or <2000 IU/mL, with continued antiviral therapy and monitoring of liver function and HBV viral load).
- Patients with severe comorbidities, including poorly controlled diabetes despite anti-diabetic medication, clinically significant active heart disease, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, hemorrhagic peptic ulcer, ileus, or intestinal obstruction.
- Patients with severe diarrhea (grade ≥2 per NCI-CTCAE v5.0: ≥4 bowel movements per day vs baseline; moderate/severe increase in stoma output; limitation of activities of daily living).
- Patients with severe psychiatric disorders.
- Patients with grade ≥II peripheral neuropathy at present or in the past.
- Patients with known hypersensitivity to benzodiazepines, AG chemotherapy agents, or related components.
- Patients who participated in other clinical trials within 4 weeks prior to enrollment.
- Patients deemed unsuitable for the trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib/II Single-Arm, Single-Center, Prospective Clinical Study Of Rimegepant Combined With AG Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
This study aims to evaluate the efficacy and safety of Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer.
Read the detailed description
This is a single-center, single-arm, prospective Phase Ib/II study designed to evaluate the clinical efficacy and safety profile of Rimegepant in combination with the AG (Nab-paclitaxel plus Gemcitabine) chemotherapy regimen as first-line treatment for patients with unresectable metastatic pancreatic cancer who have not received prior anti-pancreatic cancer therapy (surgical resection excepted).
- Being tested
- Rimegepant plus Nab-Paclitaxel and Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant plus Nab-Paclitaxel and GemcitabineDrug
Rimegepant 75 mg every other day. Nab-paclitaxel 125 mg/m² and Gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | Patients receive Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer, with assessment of efficacy and safety outcomes. Receives: Drug: Rimegepant plus Nab-Paclitaxel and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Time from randomization to disease progression or death from any cause, assessed per RECIST v1.1 and evaluated every 6 weeks during treatment and follow-up.
Measured: From randomization to disease progression or death, with follow-up for up to 2 years after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startMar 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 Metastatic Pancreatic Ductal 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiuchao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiuchao Wang, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475234
- Sponsor's protocol ID
- E20260288
- Acronym
- RAG-MPDAC
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Single-Arm, Single-Center, Prospective Clinical Study Of Rimegepant Combined With AG Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07475234
- Acronym / sponsor ID
- RAG-MPDAC / E20260288
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiuchao WangUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Mar 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 study aims to evaluate the efficacy and safety of Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer.
Detailed description
This is a single-center, single-arm, prospective Phase Ib/II study designed to evaluate the clinical efficacy and safety profile of Rimegepant in combination with the AG (Nab-paclitaxel plus Gemcitabine) chemotherapy regimen as first-line treatment for patients with unresectable metastatic pancreatic cancer who have not received prior anti-pancreatic cancer therapy (surgical resection excepted).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: Rimegepant plus Nab-Paclitaxel and GemcitabinePatients receive Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer, with assessment of efficacy and safety outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- The patient has good compliance, understands the study procedures, and has signed a written informed consent form.
- Age ≥ 18 years.
- Pathologically or cytologically confirmed pancreatic cancer, with imaging or pathological findings indicating unresectable pancreatic cancer with distant metastasis.
- Patients who have not received any prior treatment for pancreatic cancer (including radiotherapy, chemotherapy, or experimental therapy), except for surgical resection.
- If the patient has received neoadjuvant/adjuvant chemotherapy, the regimen must not contain AG, and the interval from the last administration to the diagnosis of recurrence must be >6 months, with no delayed toxicities.
Key exclusion criteria (15 listed)
- Patients with a history of other malignancies within the past 5 years, except for cured in situ carcinoma or basal cell carcinoma of the skin.
- Patients diagnosed with pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.
- Patients with refractory pleural effusion or ascites.
- Patients with known brain or meningeal metastases.
- Patients who used strong CYP3A4 inducers within 3 weeks prior to the first study drug administration, or strong CYP3A4/UGT1A1 inhibitors within 3 weeks prior to the first study drug administration.
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 |
|---|---|---|
| Rimegepant plus Nab-Paclitaxel and GemcitabineRimegepant 75 mg every other day. Nab-paclitaxel 125 mg/m² and Gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of a 21-day cycle. | Drug | Single-Arm |
Primary outcome
Progression-Free Survival
Time frame: From randomization to disease progression or death, with follow-up for up to 2 years after treatment initiation.
Time from randomization to disease progression or death from any cause, assessed per RECIST v1.1 and evaluated every 6 weeks during treatment and follow-up.
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 16 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rimegepant plus Nab-Paclitaxel and Gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Xiuchao Wang.
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 18 inclusion and 15 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 Xiuchao W Chief Physician (+86 13752038814, wangxiuchao2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: From randomization to disease progression or death, with follow-up for up to 2 years after treatment initiation.). 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 16 Mar 2026.