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Molecularly Tailored Therapy Versus Standard Care in Patients With Advanced Pancreatic Cancer Using Olaparib, Erlotinib, Crizotinib, Trametinib, Pemigatinib, Selpercatinib, Axitinib, Vismodegib, Pembrolizumab, Larotrectinib, Dabrafenib, Capecitabine, Oxaliplatin, Fluorouracil, Irinotecan, Gemcitabine, Paclitaxel Albumin-Bound, and Calcium Folinate

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 is being done in advanced pancreatic cancer, which means pancreatic cancer that has spread or cannot be removed with surgery. The purpose of the study is to compare a molecularly tailored therapy with standard care. Molecularly tailored therapy means treatment chosen based on the cancer’s specific gene or protein changes, called molecular alterations.

The study uses several cancer medicines, depending on the specific change found in the tumor. These include olaparib, erlotinib, crizotinib, trametinib, pemigatinib, selpercatinib, axitinib, vismodegib, pembrolizumab, larotrectinib, dabrafenib, and the injection Phesgo (trastuzumab and pertuzumab). Standard care medicines in the study include oxaliplatin, capecitabine, irinotecan, fluorouracil, calcium folinate, gemcitabine, and paclitaxel albumin-bound. Some medicines are taken by mouth, while others are given by injection or infusion into a vein.

During the study, people are assigned to receive either the tailored treatment or standard care. Treatment is given in repeated cycles, with regular medical visits to check health, side effects, and how the cancer is doing. The study follows people over time to see how long the cancer stays under control and how the treatments compare in safety and overall benefit.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment begins

    After you join the study, you start the assigned treatment for advanced pancreatic cancer.

    The treatment depends on the study group and may be one of the following medicines taken by mouth: olaparib 600 mg, erlotinib 150 mg, crizotinib 500 mg, trametinib 2 mg, pemigatinib 13.5 mg, selpercatinib 320 mg, axitinib 20 mg, vismodegib 150 mg, larotrectinib 200 mg, or dabrafenib 300 mg.

    Some study groups receive treatment by injection or infusion instead of tablets: pembrolizumab 200 mg is given into a vein, oxaliplatin 130 mg/m2 is given into a vein, irinotecan 200 mg/m2 is given into a vein, fluorouracil 2400 mg/m2 is given as an infusion into a vein, calcium folinate 400 mg/m2 is given into a vein, gemcitabine 1000 mg/m2 is given into a vein, and paclitaxel albumin-bound 125 mg/m2 is given into a vein.

    Some study groups receive a skin injection instead of tablets or vein treatment: phesgo is given as a subcutaneous injection, which means an injection under the skin, in either the 1200 mg/600 mg or 600 mg/600 mg form.

    The source data does not specify the exact frequency or treatment duration for each medicine, so only the listed dose and route can be stated.

  2. Step 2

    Ongoing treatment period

    You continue the assigned study treatment during the trial.

    The medicines listed for your study group are given according to the study plan, but the source data does not provide the exact schedule, frequency, or total length of treatment.

    The trial compares molecularly tailored therapy, which means treatment chosen to match the cancer’s molecular changes, with standard care, which means usual treatment used for this condition.

    The main outcome measured during this period is progression-free survival, which means the length of time before the cancer gets worse.

  3. Step 3

    Follow-up measurements during the trial

    During the trial, your progress is measured for several outcomes.

    These include overall survival, which means how long you live after starting treatment; objective response rate, which means how many people’s tumors shrink; disease control rate, which means how many people’s cancer shrinks or stays stable; duration of response, which means how long a tumor response lasts; and progression-free survival on subsequent treatment, which means the time before the cancer gets worse again after later treatment.

    The trial also checks for adverse events, which means unwanted effects or side effects caused by the study treatment.

    Your general health status, quality of life, and symptoms are also measured with the eortc qlq-c30 questionnaire, which is a patient form used to assess daily well-being and symptoms.

  4. Step 4

    Trial end and final assessment period

    The trial continues until the study period ends or your participation in the assigned treatment ends according to the study plan.

    The source data gives the overall trial period from 2026-10-01 to 2032-06-30, but it does not give an individual treatment length for you.

    Final study results are based on the outcomes listed in the trial, including survival, cancer response, side effects, and quality of life.

Who can join the trial?

13 criteria

  • Be an adult, meaning 18 years of age or older.
  • Have pancreatic cancer confirmed by a laboratory test on tissue or cells, called cytology or histology.
  • Provide written informed consent before any study-specific procedures. This means the person must sign a form showing they understand the study and agree to take part.
  • Have an available personalized report with the results of molecular testing and the treatment options based on those results. Molecular testing means testing the cancer for specific changes in its genes or other markers.
  • Have already received 1 line of systemic chemotherapy for advanced disease and have had the cancer get worse during or after that treatment, or within 1 year after adjuvant or neoadjuvant treatment. Systemic chemotherapy means anti-cancer medicine that travels through the whole body. Adjuvant treatment is treatment given after the main treatment. Neoadjuvant treatment is treatment given before the main treatment.
  • Have a ECOG Performance Status of 0 to 2, which means the person must be well enough to do most daily activities, with some possible limits. ECOG Performance Status is a scale that measures how active and independent a person is.
  • Have normal organ and bone marrow function, shown by the following test results:
    • Absolute neutrophil count of at least 1.5 x 10⁹/L. Neutrophils are a type of white blood cell that help fight infection.
    • Platelet count of at least 75 x 10⁹/L. Platelets help the blood clot.
    • Serum bilirubin of 1.5 times the upper limit of normal or lower. Bilirubin is a substance measured in the blood that can show how well the liver is working.
    • AST and ALT of 5 times the upper limit of normal or lower. AST and ALT are liver enzymes, which are proteins that help the body work and can rise when the liver is stressed or damaged.
    • Serum creatinine of 1.5 times the upper limit of normal or lower, or creatinine clearance of at least 50 mL/min. Creatinine is a waste product measured to check kidney function, and creatinine clearance shows how well the kidneys remove waste from the blood.
    • If the participant is a woman who can become pregnant, she must use the birth control method or methods required by the study rules.
    • If the participant is a man who is sexually active with a woman who can become pregnant, he must use a birth control method with a very low chance of failure, meaning less than 1% per year.

Who cannot join the trial?

5 criteria

  • Any serious or uncontrolled medical condition that, in the investigator’s opinion, could increase the risk of taking part in the study, make it hard to receive the study treatment, or affect how the study results are understood. Uncontrolled means the condition is not well managed.
  • A history of allergy to any part of the study drug. An allergy means the body reacts in a harmful way to a medicine or one of its ingredients.
  • Hypersensitivity to the active substances in the study drug. Hypersensitivity means an unusually strong or harmful reaction to the medicine itself.
  • Women who are able to become pregnant and are currently pregnant.
  • Women who are able to become pregnant and are breastfeeding.
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Investigated drugs

Olaparib is an oral targeted cancer medicine used in this trial as one of the personalized treatment options. It is given by mouth and is meant to attack cancer cells that have specific DNA repair problems, with the goal of slowing or stopping tumor growth.

Erlotinib is an oral targeted therapy used in this trial as a treatment option for some patients based on their tumor’s molecular features. It works by blocking signals that help cancer cells grow and divide.

Crizotinib is an oral targeted medicine included as a trial treatment for patients whose cancer has certain changes that may respond to this drug. It is designed to block growth signals that can help the cancer spread.

Oxaliplatin is a chemotherapy medicine given into a vein and used here as part of standard care. It helps kill cancer cells by damaging their ability to grow and reproduce.

Trametinib is an oral targeted therapy used in the trial for patients whose cancer has a matching molecular change. It blocks a growth pathway inside cancer cells to help slow the disease.

Pemigatinib is an oral targeted cancer medicine used as a personalized treatment option in this study. It is meant to block signals that certain cancer cells use to grow.

Selpercatinib is an oral targeted therapy included for patients with specific tumor changes that may make this medicine useful. It works by blocking a protein that can drive cancer growth.

Axitinib is an oral targeted medicine used in the trial as a tailored treatment option. It helps stop the growth of blood vessels that tumors need to grow and spread.

Vismodegib is an oral targeted therapy used for patients whose cancer has a matching molecular feature. It blocks a growth pathway that can be active in some cancers.

Pembrolizumab is an intravenous immunotherapy used in this trial as a treatment option for some patients. It helps the immune system recognize and attack cancer cells more effectively.

Larotrectinib is an oral targeted therapy given to patients whose tumor has a specific gene change that may respond to it. It blocks a signal that can tell cancer cells to keep growing.

Dabrafenib is an oral targeted medicine used in the study for cancers with a certain gene change. It blocks a growth signal inside cancer cells to help slow the disease.

Capecitabine is an oral chemotherapy medicine used here as standard care. After it is taken by mouth, the body changes it into a drug that helps kill cancer cells.

Irinotecan is a chemotherapy medicine given into a vein and used as part of standard care in this trial. It works by damaging cancer cells so they cannot keep dividing.

Fluorouracil is a chemotherapy medicine given by intravenous infusion and used as standard care. It interferes with cancer cells’ ability to make new DNA, which helps stop their growth.

Calcium folinate is a supportive medicine given into a vein and used together with some chemotherapy treatments in standard care. It helps strengthen the effect of certain cancer drugs.

Gemcitabine is a chemotherapy medicine given into a vein and used as standard care. It works by preventing cancer cells from making new DNA and dividing.

Paclitaxel albumin-bound is a chemotherapy medicine given into a vein and used as standard care. It helps stop cancer cells from dividing and growing.

Trastuzumab and pertuzumab are targeted cancer medicines given as a subcutaneous injection together in a single product called Phesgo. They are used for tumors with HER2-related changes and work by blocking signals that help cancer cells grow.

What is already known about the treatment

  • Olaparib

    Olaparib is an oral medicine taken by mouth as tablets or capsules, and it is used in cancer treatment, especially when a tumor has certain DNA repair problems. It is still an important and well-studied drug in medical literature, with approved uses in several cancers. It belongs to a group called PARP inhibitors, and it works by blocking a protein that helps damaged cancer cells fix their DNA, which can lead to cancer cell death.

  • Erlotinib

    Erlotinib is an oral medicine taken by mouth, usually as tablets, and it is used to treat some cancers that depend on abnormal growth signals. It remains a recognized cancer drug in medical literature, although its use is now more limited than some newer targeted medicines. It is an epidermal growth factor receptor blocker, meaning it blocks a protein on cancer cells that tells them to grow and divide.

  • Crizotinib

    Crizotinib is an oral medicine taken by mouth as capsules or tablets, and it is used for certain cancers that have specific gene changes. It is well known in medical literature as a targeted cancer treatment. It belongs to the group of protein kinase inhibitors, and it works by blocking signals from abnormal proteins that help cancer cells grow and survive.

  • Oxaliplatin

    Oxaliplatin is given by intravenous infusion, which means it is delivered directly into a vein by a healthcare professional. It is a widely used and well-established chemotherapy drug in cancer care. It belongs to the platinum-based anticancer medicines, and it works by damaging the DNA of cancer cells so they cannot grow and divide normally.

  • Trametinib

    Trametinib is an oral medicine taken by mouth as tablets, and it is used for some cancers with changes in the MAPK growth pathway. It is a known targeted therapy in medical literature and is used in selected cancer types. It belongs to the MEK inhibitor class, and it works by blocking a signal protein that helps cancer cells grow and multiply.

  • Pemigatinib

    Pemigatinib is an oral medicine taken by mouth as tablets, and it is used for cancers with certain FGFR gene changes. It is a newer targeted cancer medicine and is well described in current medical literature. It belongs to the fibroblast growth factor receptor inhibitor class, and it works by blocking signals from FGFR proteins that can drive tumor growth.

Investigated diseases

Advanced pancreatic cancer - This is pancreatic cancer that has grown beyond the pancreas and is no longer confined to the original site. It usually progresses by invading nearby tissues and may spread to lymph nodes or distant organs. As it advances, the cancer can become harder to control and may cause worsening symptoms over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522431-34-00Protocol codePA 2506Estimated enrolment1 200 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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