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Study of Galunisertib and Capecitabine for Patients with Advanced Chemotherapy-Resistant Colorectal Cancer with Peritoneal Metastases

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 type of cancer known as colorectal cancer, which affects the colon and rectum. The study is specifically looking at cases where the cancer has spread to the lining of the abdomen, known as peritoneal metastases, and is resistant to standard chemotherapy treatments. The trial will test a combination of two medications: galunisertib (also known by its code name LY2157299) and capecitabine. Both medications are taken orally in the form of film-coated tablets.

The purpose of this study is to gather more information about how these medications work together, their safety, and how well they are tolerated by patients. The study will be conducted in two phases. In the first phase, the focus will be on determining the safety and appropriate dosage of the combination treatment. The second phase will assess the effectiveness of the treatment in reducing the cancer. Participants will take the medications and undergo regular check-ups to monitor their health and the cancer's response to the treatment.

Throughout the study, researchers will collect data on any side effects experienced by participants and how the medications are processed in the body. This information will help in understanding the potential benefits and risks of using galunisertib and capecitabine together for treating advanced colorectal cancer with peritoneal metastases. The study aims to provide valuable insights that could lead to improved treatment options for patients with this challenging form of cancer.

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

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of colorectal cancer with peritoneal metastases and ensuring previous treatment with fluoropyrimidine chemotherapy has been ineffective.

    Laboratory tests are performed to check blood counts, liver and kidney function, and a pregnancy test for women of childbearing potential. The ability to swallow tablets is also confirmed.

  2. Step 2

    Informed consent

    Before starting the trial, written informed consent is required. This document explains the study details, potential risks, and benefits. Signing this form indicates understanding and agreement to participate.

  3. Step 3

    Baseline evaluations

    Baseline evaluations include a physical examination, blood sampling for pharmacokinetic analysis, and a tumor biopsy. These assessments provide a starting point for monitoring changes during the trial.

  4. Step 4

    Treatment phase

    The treatment involves taking two medications: capecitabine and galunisertib. Capecitabine is administered in the form of 150 mg and 500 mg film-coated tablets, taken orally. Galunisertib is also taken orally, with dosages ranging from 80 to 150 mg.

    The specific dosage and frequency of administration are determined by the study protocol and adjusted based on individual response and tolerance.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess safety and effectiveness. This includes periodic blood tests, imaging studies, and additional tumor biopsies as required.

    The study aims to evaluate the safety, tolerability, and anti-tumor activity of the medication combination. Monitoring continues throughout the treatment duration and includes assessments of any side effects experienced.

  6. Step 6

    End of treatment

    At the end of the treatment phase, a final evaluation is conducted. This includes a comprehensive review of the patient's response to the treatment and any side effects encountered.

    The study's primary goal is to determine the optimal dosage and assess the anti-tumor activity of the medication combination. Secondary goals include understanding the safety profile and pharmacokinetics.

Who can join the trial?

16 criteria

  • Must have a confirmed diagnosis of **colorectal cancer** with at least confirmed **peritoneal metastases** (cancer spread to the lining of the abdomen). Other cancer spread outside the abdomen is allowed.
  • Must have experienced disease progression or relapse after treatment for advanced colorectal cancer with chemotherapy containing **fluoropyrimidine** (a type of cancer drug), with no other treatment options available.
  • Must be **18 years or older**.
  • Must be able and willing to provide written informed consent, which means agreeing to participate in the study after understanding all the details.
  • Must have a **WHO performance status** of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must be able and willing to undergo blood sampling for **PK analysis** (a test to see how the drug is processed in the body).
  • Must be able and willing to undergo a **tumor biopsy** (a procedure to take a small sample of tissue) before starting, during, and at the end of treatment.
  • Must have a **life expectancy** of more than 3 months, which means being expected to live long enough to follow up on treatment effects.
  • Must have **evaluable disease** according to **RECIST 1.1 criteria**, which is a standard way to measure how well a cancer treatment works.
  • Must meet certain **safety laboratory values**:
    • **ANC** (a type of white blood cell count) of at least 1.5 x 109/L.
    • **Platelet count** of at least 100 x 109/L.
    • **Hepatic function** (liver function) with serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), and **ALAT** and **ASAT** (liver enzymes) ≤ 3 times ULN, or < 5 times ULN if there are liver metastases.
    • **Renal function** (kidney function) with serum creatinine ≤ 1.5 times ULN.
    • **Creatinine clearance** (a measure of kidney function) of at least 50 ml/min.
    • Female patients with childbearing potential must have a **negative pregnancy test** (urine or blood test).
    • Must be able and willing to **swallow tablets**.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than colorectal cancer cannot participate. Colorectal cancer is a type of cancer that starts in the colon or rectum, which are parts of the large intestine.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not eligible to participate.
  • Patients who have medical conditions or are taking medications that could interfere with the study treatment cannot participate.
  • Patients who have had a recent surgery or medical procedure that could affect the study results cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible to participate in the study.
  • Patients who have participated in another clinical trial recently may not be eligible to participate in this study.
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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

  • Galunisertib

    is an experimental medication being studied for its potential to treat advanced colorectal cancer. It works by targeting specific pathways in cancer cells, which may help to slow down or stop the growth of the cancer. In this trial, it is being tested to see how well it works when combined with another medication.

  • Capecitabine

    is a chemotherapy drug that is commonly used to treat various types of cancer, including colorectal cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this study, capecitabine is used in combination with galunisertib to see if the two drugs together can be more effective in treating cancer that has spread to the peritoneum, which is the lining of the abdominal cavity.

What is already known about the treatment

  • Galunisertib

    This medication is administered orally and is currently being studied in clinical trials for its potential use in treating advanced colorectal cancer, particularly in cases resistant to chemotherapy. It is not yet widely used in standard medical practice, as it is still under investigation. Galunisertib works by inhibiting specific proteins involved in cancer cell growth, aiming to slow down or stop the progression of the disease. It is classified as a kinase inhibitor, targeting molecular pathways that contribute to tumor development.

  • Capecitabine

    This medication is also taken orally and is an established treatment for various types of cancer, including colorectal cancer. It is used in combination with other drugs, such as galunisertib, to enhance its effectiveness. Capecitabine is a prodrug, meaning it is converted into its active form, 5-fluorouracil, inside the body, where it interferes with DNA synthesis in cancer cells, preventing their growth and division. It belongs to the class of antimetabolites, which are commonly used in chemotherapy.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that starts in the colon or rectum, which are parts of the large intestine. It often begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the cancer progresses, it can invade and destroy nearby tissue and spread to other parts of the body. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others may spread to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518980-37-00Protocol codeM22TGAEstimated enrolment31 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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