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Study on Napabucasin, Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer After Chemotherapy Failure

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for people with metastatic pancreatic cancer, which is a type of cancer that has spread from the pancreas to other parts of the body. The study is investigating how well an investigational drug called Napabucasin works when combined with two chemotherapy drugs, Paclitaxel and Gemcitabine. These medications are given to patients who have already tried other chemotherapy treatments that did not work.

The purpose of the study is to compare the effects of the combination of Napabucasin, Paclitaxel, and Gemcitabine with standard treatment options. Participants will receive these medications through an infusion, which means the drugs are delivered directly into the bloodstream through a vein. The study will be conducted in two phases. In the first phase, the focus will be on how long patients can live without the cancer getting worse and the safety of the treatment. In the second phase, the study will look at the overall survival of patients, which means how long they live after starting the treatment.

Participants in the study will be randomly assigned to receive either the investigational treatment or a standard treatment. The study will continue for several years, and patients will be monitored regularly to assess their health and the effects of the treatment. The goal is to find out if the new combination of drugs can help improve outcomes for people with metastatic pancreatic cancer after other treatments have failed.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests are performed to ensure adequate blood counts and chemistry levels. Imaging tests such as CT or MRI scans are conducted to evaluate the presence of metastatic tumors.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving the investigational treatment and the other receiving standard care.

    The investigational treatment group receives a combination of napabucasin, paclitaxel, and gemcitabine.

  3. Step 3

    Treatment administration

    For the investigational group, napabucasin is taken orally in capsule form. The dosage and frequency are determined by the study protocol.

    Paclitaxel and gemcitabine are administered intravenously. The specific dosage and schedule are outlined in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health status and response to treatment. This includes physical exams, blood tests, and imaging studies.

    Safety and any side effects are closely monitored throughout the study duration.

  5. Step 5

    Study completion

    Upon completion of the treatment phase, a final assessment is conducted to evaluate overall health and treatment outcomes.

    Participants may be asked to return for additional follow-up visits to assess long-term effects and overall survival.

Who can join the trial?

23 criteria

  • The patient must provide a written, signed consent to participate in the trial.
  • The patient must have certain blood counts at the start, including:
    • Absolute neutrophil count (ANC) of at least 1.5 x 109/L.
    • Platelet count of at least 100,000/mm3.
    • Hemoglobin (Hgb) of at least 9 g/dL.
    • The patient must have specific blood chemistry levels at the start, including:
      • AST (SGOT) and ALT (SGPT) levels no more than 2.5 times the normal limit (or 5 times if there are liver metastases).
      • Total bilirubin no more than 1.5 times the normal limit. If higher, it must not be increasing for at least 3 days.
      • Serum creatinine within normal limits or clearance greater than 60 mL/min/1.73 m2.
      • If not on blood thinners, the patient must have normal blood clotting tests.
      • The patient must not have significant abnormalities in urine tests.
      • The patient must have a Body Mass Index (BMI) of at least 18 kg/m2 and weigh at least 40 kg, with a serum albumin level of at least 3 g/dL.
      • If a biliary stent is needed, it must be placed at least 7 days before screening.
      • Pain symptoms should be stable and manageable.
      • If tumor tissue is available, the patient must agree to provide it for testing.
      • The patient must be available for treatment and follow-up visits.
      • The patient must not be participating in another clinical study and must agree not to join other studies during this trial.
      • The patient must have confirmed advanced pancreatic cancer that has spread to other parts of the body.
      • The patient must have tried at least one chemotherapy treatment that did not work, including treatments like gemcitabine or FOLFIRINOX.
      • The patient must have one or more tumors that can be measured by a CT scan or MRI.
      • The patient must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
      • The patient must have a life expectancy of more than 12 weeks.
      • The patient must be at least 18 years old.
      • If the patient can have children, they must agree to use birth control during the study and for a certain time after the last dose of treatment.
      • Women who can have children must have a negative pregnancy test within 3 days before starting the trial.

Who cannot join the trial?

4 criteria

  • Patients who do not have a confirmed diagnosis of advanced pancreatic adenocarcinoma that has spread to other parts of the body.
  • Patients who have not experienced failure with previous chemotherapy treatments.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Napabucasin

    is an experimental medication being studied for its potential to treat metastatic pancreatic cancer. It is being tested in combination with other cancer treatments to see if it can help improve outcomes for patients whose cancer has not responded to previous chemotherapy.

  • Paclitaxel

    is a chemotherapy drug used to treat various types of cancer, including pancreatic cancer. In this study, it is given weekly to help stop the growth of cancer cells by interfering with their ability to divide.

  • Gemcitabine

    is another chemotherapy medication used to treat pancreatic cancer. In this trial, it is given in low doses to work alongside other treatments, aiming to enhance their effectiveness in controlling cancer growth.

What is already known about the treatment

Napabucasin – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating metastatic pancreatic cancer. It is not yet widely used in standard medical practice, as it is still under investigation. Napabucasin is being evaluated for its ability to improve progression-free survival and overall survival in patients who have not responded to previous chemotherapy treatments. It works by targeting cancer stem cells and disrupting their signaling pathways, which may help to inhibit tumor growth. Napabucasin is classified as an anti-cancer agent.

Investigated diseases

Pancreatic Adenocarcinoma – This is a type of cancer that begins in the tissues of the pancreas, an organ located behind the lower part of the stomach. It is characterized by the abnormal growth of cells in the pancreatic ducts, which can form a tumor. As the disease progresses, it can spread to nearby organs and tissues, including the liver and lymph nodes. Symptoms may include abdominal pain, weight loss, and jaundice, although they often appear only in advanced stages. The disease is often diagnosed at a late stage due to its subtle early symptoms. It is known for its aggressive nature and tendency to metastasize, or spread, to other parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-518205-17-00Protocol codeSTEMNESS-PANCEstimated enrolment336 patientsSponsor1globe Health Institute LLC

sourced from the EU Clinical Trials Register and site verification

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