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Study of trametinib and hydroxychloroquine in patients with metastatic pancreatic cancer that has not responded to previous treatment

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 focuses on patients with metastatic refractory pancreatic cancer, which is an advanced form of pancreatic cancer that has spread to other parts of the body and has not responded to at least one previous treatment. The study will test a combination of two medications: trametinib and hydroxychloroquine. Both medications are given as film-coated tablets that are taken by mouth.

The purpose of this study is to determine how well patients respond to this combination treatment over a twelve-week period. Specifically, researchers want to see if the treatment can stop or slow down the progression of cancer during this time. The treatment period may last up to 12 months, during which patients will receive regular medical check-ups and imaging scans to monitor their condition.

During the study, patients will take both medications daily according to a specified schedule. Trametinib will be given at doses up to 2 mg per day, while hydroxychloroquine will be administered at doses up to 1200 mg per day. Doctors will monitor patients throughout the study to check for any side effects and to evaluate how well the treatment is working.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo a medical assessment to confirm metastatic pancreatic cancer diagnosis and verify eligibility for the study.

    Basic health checks will be performed, including blood tests to evaluate organ function and general health status.

  2. Step 2

    Baseline imaging

    A CT scan of your chest, abdomen, and pelvis will be performed to establish the current status of your condition.

    The scan results will serve as a reference point for future comparisons.

  3. Step 3

    Treatment initiation

    You will receive two medications to take by mouth:

    Trametinib (Mekinist) tablets - available in 2 mg and 0.5 mg strengths

    Hydroxychloroquine (Accord) 200 mg tablets

  4. Step 4

    6-week assessment

    A CT scan will be performed to evaluate how your condition is responding to the treatment.

    Your general health and any side effects will be monitored.

  5. Step 5

    12-week assessment

    Another CT scan will be performed to evaluate the progression of your condition.

    This is a key milestone in determining how effective the treatment has been.

  6. Step 6

    Ongoing monitoring

    After the 12-week mark, CT scans will be performed every 8 weeks.

    Regular health assessments will continue to monitor your response to treatment and any side effects.

    This monitoring will continue until either the disease progresses or you choose to withdraw from the study.

Who can join the trial?

13 criteria

  • Must have confirmed advanced metastatic pancreatic cancer (cancer that has spread from pancreas to other parts of body) that can be biopsied
  • Must have received at least one previous treatment for metastatic cancer and not be suitable for surgery
  • Must have cancer that can be measured using specific imaging criteria (RECIST 1.1)
  • Must be 18 years or older
  • Must have good physical ability to perform daily activities (ECOG status of 0 or 1)
  • Must have normal organ and bone marrow function, including:
    • Normal kidney function (creatinine levels)
    • Normal liver function (bilirubin, AST, and ALT levels)
    • Normal blood cell counts (neutrophils, platelets, and hemoglobin)
    • Must be able to understand and sign an informed consent document
    • If able to have children, must agree to use effective birth control methods during the study and for 16 weeks after, such as:
      • Hormonal contraception (pills, patches, implants)
      • Intrauterine devices (IUD)
      • Surgical methods (tubal ligation or vasectomy)
      • Complete abstinence

Who cannot join the trial?

14 criteria

  • Prior treatment with MEK inhibitors (drugs that block specific proteins involved in cancer growth)
  • Known allergy or sensitivity to hydroxychloroquine or similar medications
  • Presence of active autoimmune disease (conditions where the body's immune system attacks healthy cells) requiring systemic treatment
  • Uncontrolled heart conditions, including:
    • Unstable angina (chest pain)
    • Heart failure
    • Recent heart attack
    • Significant eye problems, particularly retinopathy (damage to the retina of the eye)
    • Severe liver dysfunction
    • Pregnancy or breastfeeding
    • Active brain metastases (cancer that has spread to the brain) unless treated and stable
    • Other active cancers requiring treatment
    • Any condition that would make the patient unable to comply with the study requirements
    • Participation in another clinical trial within 30 days before starting this study
    • Major surgery within 4 weeks before starting the study
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Investigated drugs

  • Trametinib

    is a medication used to treat cancer. It works by blocking specific proteins that can cause cancer cells to grow and spread. In this trial, it is being studied as a treatment for pancreatic cancer that has spread to other parts of the body and hasn't responded well to previous treatments.

  • Hydroxychloroquine

    is a medication that was originally used to treat malaria and certain autoimmune conditions. In cancer treatment, it may help make cancer cells more sensitive to other treatments by interfering with their survival mechanisms. In this trial, it is being studied in combination with trametinib to see if together they can help control pancreatic cancer that has spread and become resistant to other treatments.

What is already known about the treatment

  • Trametinib

    An oral medication administered in tablet form that belongs to the class of MEK inhibitors used in cancer treatment. This targeted therapy works by blocking specific proteins (MEK1 and MEK2) that are involved in cancer cell growth and survival, particularly in cases of advanced pancreatic cancer. The medication helps to slow down or stop the growth of cancer cells by interrupting cellular signaling pathways that promote tumor development.

  • Hydroxychloroquine

    An oral medication traditionally used for malaria prevention and treatment of autoimmune conditions, which is now being studied in cancer therapy. It works by blocking autophagy, a cellular recycling process that cancer cells often use to survive during stress conditions and resist treatment. In pancreatic cancer research, it is being investigated in combination with other medications to potentially enhance their effectiveness and overcome treatment resistance.

Investigated diseases

Metastatic Pancreatic Cancer - A condition where cancer cells originating in the pancreas spread to other parts of the body. The pancreas is an organ located behind the stomach that produces hormones and digestive enzymes. In this disease, abnormal cells from a tumor in the pancreas break away and travel through the bloodstream or lymphatic system to form new tumors in other organs. This spread commonly affects the liver, lungs, and nearby lymph nodes. The cancer cells continue to grow and multiply in these new locations, forming additional tumors that affect the function of the invaded organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513429-21-00Protocol code20-27 PaTcHEstimated enrolment22 patientsSponsorCancer Trials Ireland

sourced from the EU Clinical Trials Register and site verification

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