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Study of sotorasib with chemotherapy combination for adult patients with advanced pancreatic cancer who have KRAS p.

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 study focuses on treating patients with advanced pancreatic adenocarcinoma that has a specific genetic change called KRAS p.G12C mutation. The main treatment being tested is a drug called sotorasib (also known as LUMYKRAS) used together with standard chemotherapy medications.

The chemotherapy drugs that will be combined with sotorasib include paclitaxel, oxaliplatin, fluorouracil, calcium folinate, irinotecan, and gemcitabine. Sotorasib is taken as tablets by mouth, while the chemotherapy medications are given through an intravenous infusion (through a vein). The purpose of this study is to determine if this combination of treatments is safe and well-tolerated by patients.

During the study, patients will receive sotorasib tablets daily along with their scheduled chemotherapy treatments. Doctors will monitor patients' health through regular check-ups, blood tests, and imaging scans to assess how well the treatment is working and to watch for any side effects. The treatment may continue for up to 9 months, depending on how well the patient responds and tolerates the medications.

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 treatment phase

    You will receive treatment for advanced pancreatic cancer that combines oral medication with intravenous chemotherapy.

    The oral medication (sotorasib) comes in the form of 240 mg film-coated tablets.

    The intravenous medications include: paclitaxel, calcium folinate, oxaliplatin, fluorouracil, irinotecan, and gemcitabine.

  2. Step 2

    Regular medical assessments

    Your health status will be monitored through regular physical examinations.

    Blood tests will be performed to check your blood count, liver function, and kidney function.

    Imaging tests (CT or MRI scans) will be conducted to measure how your cancer responds to treatment.

  3. Step 3

    Safety monitoring

    Any side effects or health changes will be recorded and assessed using standardized criteria.

    Laboratory tests will be regularly performed to monitor your body's response to the treatment.

    Your vital signs will be checked during treatment visits.

  4. Step 4

    Treatment duration

    The treatment will continue as long as it provides benefit and is well-tolerated.

    The study is planned to run until March 31, 2030.

    Your participation may end earlier based on your response to treatment or other factors.

  5. Step 5

    Follow-up assessments

    Regular follow-up visits will track your overall survival and cancer progression.

    Imaging scans will continue to monitor your response to treatment.

    Blood samples will be collected to measure medication levels in your body.

Who can join the trial?

9 criteria

  • Must be able and willing to give informed consent
  • Must be at least 18 years old (men or women)
  • Must use effective birth control methods or practice sexual abstinence: - Women must continue contraception for 7 days after last dose of sotorasib, 6 months after gem/nab-P, and 15 months after mFOLFIRINOX - Men must use contraception for 12 months after stopping mFOLFIRINOX
  • Must have confirmed pancreatic cancer that has spread locally or to other parts of the body, with a specific genetic change called KRAS p.G12C mutation
  • Must have cancer that can be measured using standard imaging techniques
  • Must be able to perform daily activities with minimal assistance (ECOG score of 0 or 1)
  • Must have a life expectancy of more than 3 months
  • Must have adequate blood test results showing: - Sufficient white blood cells - Adequate hemoglobin levels - Sufficient platelet count - Acceptable liver function tests - Normal kidney function
  • Must be able to take oral medications and willing to record daily medication use

Who cannot join the trial?

13 criteria

  • Prior treatment with any KRAS G12C inhibitor (medications targeting specific genetic mutations)
  • Active brain metastases (cancer that has spread to the brain) that are not treated and stable
  • History of other cancers within 3 years before starting the study, except for adequately treated non-melanoma skin cancer or cervical cancer
  • Autoimmune diseases (conditions where the immune system attacks healthy cells) requiring systemic treatment
  • Serious heart conditions, including:
    • Heart attack within the last 6 months
    • Unstable chest pain
    • Severe heart rhythm problems
    • Active, uncontrolled infections requiring treatment
    • Known allergy or sensitivity to any of the study medications
    • Pregnant or breastfeeding women
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
    • Unable to swallow oral medications
    • Severe liver or kidney problems
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Investigated drugs

  • Sotorasib

    is a medication that targets specific genetic mutations in cancer cells, particularly those with KRAS p.G12C mutation. It works by blocking the abnormal protein that drives cancer growth in pancreatic tumors. This medication is designed to be used in combination with standard chemotherapy treatments for patients with advanced pancreatic cancer.

  • Chemotherapy

    refers to standard first-line cancer-fighting drugs used to treat advanced pancreatic cancer. These medications work by killing rapidly dividing cells throughout the body, including cancer cells. When combined with sotorasib, these treatments aim to provide a more effective approach to fighting pancreatic cancer.

What is already known about the treatment

Sotorasib - A targeted oral medication used in the treatment of advanced pancreatic adenocarcinoma, specifically in patients with KRAS p.G12C mutation. This novel drug works by selectively inhibiting the KRAS G12C protein, which is responsible for cancer cell growth and survival in certain types of tumors. Sotorasib belongs to the class of precision oncology medications known as KRAS inhibitors and is administered in combination with first-line chemotherapy to improve treatment outcomes in patients with locally advanced or metastatic pancreatic cancer. The drug represents a significant advancement in targeted cancer therapy, offering a more personalized approach to treating specific genetic mutations in pancreatic cancer.

Investigated diseases

Pancreatic Adenocarcinoma - A type of cancer that develops in the cells of the pancreas, specifically in the ducts that carry digestive enzymes. The disease typically starts in the pancreatic tissue and can spread to nearby organs. As the disease progresses, the cancerous cells can affect the normal functioning of the pancreas, impacting both its digestive and hormone-producing functions. The condition may cause changes in how the body processes food and nutrients. When in advanced stages, it can extend beyond the pancreas to nearby structures.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516233-12-00Protocol codeTTD-24-01 (PANSOTO)Estimated enrolment15 patientsSponsorAsociacion Grupo Tratamiento De Tumores Digestivos

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