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Study of Romiplostim Treatment for Chemotherapy-induced Low Blood Platelets in Adults with Gastrointestinal, Pancreatic, or Colorectal Cancer Receiving Oxaliplatin Chemotherapy

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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 patients who have chemotherapy-induced thrombocytopenia while receiving treatment for gastrointestinal cancer, pancreatic cancer, or colorectal cancer. Thrombocytopenia is a condition where the blood platelet count becomes too low, which can occur as a side effect of chemotherapy. The study aims to evaluate whether a medication called romiplostim can help maintain proper platelet levels during chemotherapy treatment.

The study will test romiplostim (also known as AMG 531) against a placebo. The medication will be given as an injection under the skin. Patients will receive either the study medication or placebo while undergoing their regular oxaliplatin-based chemotherapy. The treatment period will last for 21 days, and the maximum daily dose will be 10 micrograms per kilogram of body weight.

During the study, patients will continue their planned chemotherapy treatments while receiving either romiplostim or placebo. The main focus will be on whether the medication can help patients receive their full chemotherapy doses on schedule without needing to reduce or delay treatment due to low platelet counts. Doctors will monitor platelet levels and check for any side effects throughout the study period.

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 evaluation

    Your platelet count will be checked. To qualify, your count must be 85,000 platelets or less per microliter of blood.

    You must have at least 3 planned cycles of chemotherapy remaining in your treatment.

    Your physical condition will be assessed using the ECOG scale (a measure of your daily living abilities).

  2. Step 2

    Assignment to treatment group

    You will be randomly assigned to receive either romiplostim or placebo (an inactive substance).

    Neither you nor your doctor will know which treatment you are receiving.

    The medication will be provided in identical vials for injection under the skin.

  3. Step 3

    Treatment period

    You will receive your assigned treatment while continuing your chemotherapy regimen.

    Your chemotherapy may include combinations of medications such as oxaliplatin with other drugs, given every 14 or 21 days.

    Your platelet counts will be monitored regularly throughout the treatment period.

    Blood samples will be taken to check for antibodies and monitor your health status.

  4. Step 4

    Monitoring phase

    Your doctor will monitor for any side effects or bleeding events.

    Regular blood tests will check your platelet levels.

    The study will track how well you can maintain your planned chemotherapy schedule without delays or dose reductions due to low platelet counts.

    Your overall health status and survival will be monitored throughout the study period.

  5. Step 5

    Study completion

    The study will continue through March 2025.

    Final evaluations will include assessment of your platelet count response and any side effects experienced during the study.

    Your overall health status will be documented at the end of your participation.

Who can join the trial?

8 criteria

  • You must provide informed consent before participating in any study activities
  • You must be 18 years or older
  • You must have a confirmed diagnosis of gastrointestinal, pancreatic, or colorectal cancer (including cancers of the esophagus, stomach, pancreas, colon, or rectum)
  • You must be receiving specific chemotherapy treatments: - Oxaliplatin-based chemotherapy with 5-FU or capecitabine - Or have low platelet count from previous chemotherapy and planning to start one of these treatments
  • Your platelet count must be equal to or below 85,000 per microliter of blood on the first day of the study
  • You must have waited at least: - 14 days after your last FOLFOX, FOLFIRINOX, or FOLFOXIRI treatment - 21 days after your last CAPEOX treatment
  • You must have at least 3 planned chemotherapy cycles remaining
  • Your physical ability status (ECOG) must be rated as 0, 1, or 2, meaning you must be able to care for yourself and be up and about more than 50% of waking hours

Who cannot join the trial?

15 criteria

  • History of blood clotting disorders or current blood clots
  • Previous treatment with romiplostim (the study medication)
  • Known allergies to any components of the study medication
  • Active bleeding or high risk of bleeding
  • Severe liver disease (problems with liver function)
  • Severe kidney disease (problems with kidney function)
  • Uncontrolled high blood pressure
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within the last 30 days
  • Any other type of cancer besides gastrointestinal, pancreatic, or colorectal cancer
  • Mental conditions that could affect the ability to provide informed consent
  • History of bone marrow disorders other than chemotherapy-induced thrombocytopenia (low blood platelet count caused by chemotherapy)
  • Active infections requiring treatment
  • Major surgery within the past 4 weeks
  • Life expectancy less than 6 months
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Investigated drugs

  • Romiplostim

    is a medication that helps increase the number of platelets in the blood. It is used to treat low platelet counts caused by chemotherapy treatment. This medication helps patients maintain their scheduled cancer treatments by managing their platelet levels.

  • Oxaliplatin

    is a chemotherapy medication used to treat various types of cancer, including gastrointestinal, pancreatic, and colorectal cancers. It works by interfering with cancer cell growth and division. This medication is commonly used as part of cancer treatment plans but can cause a decrease in platelet counts as a side effect.

What is already known about the treatment

  • Romiplostim

    A prescription medication administered via subcutaneous injection that stimulates platelet production in the body. It belongs to the class of drugs known as thrombopoietin receptor agonists and works by binding to and activating the thrombopoietin receptor, which leads to increased platelet production in bone marrow. This medication is primarily used to treat chemotherapy-induced thrombocytopenia (low blood platelet count) in adult patients receiving chemotherapy for gastrointestinal, pancreatic, or colorectal cancer, helping to maintain planned chemotherapy schedules by preventing delays or dose reductions due to low platelet counts. Clinical trials have shown its effectiveness in managing platelet levels during cancer treatment, allowing patients to receive their full prescribed chemotherapy doses on time.

  • Oxaliplatin

    A platinum-based chemotherapy drug administered intravenously that belongs to the class of alkylating agents. It works by forming cross-links in DNA, which prevents cancer cells from dividing and ultimately leads to their death. This medication is commonly used as part of chemotherapy regimens for treating gastrointestinal cancers, particularly colorectal cancer, and is often combined with other chemotherapy drugs to enhance treatment effectiveness. While effective against cancer cells, oxaliplatin can cause side effects including thrombocytopenia, which may require additional management strategies during treatment.

Investigated diseases

  • Chemotherapy-induced Thrombocytopenia

    A condition that occurs when chemotherapy treatment reduces the number of platelets in the blood. This condition develops as a side effect of cancer treatment, specifically affecting patients receiving chemotherapy for gastrointestinal, pancreatic, or colorectal cancers. The platelet count drops below normal levels, which happens because chemotherapy affects the bone marrow's ability to produce new platelets. The condition typically develops within days or weeks after starting chemotherapy treatment. The severity can vary between cycles of chemotherapy.

  • Gastrointestinal Cancer

    A group of cancers that affect the digestive system organs. The cancer can develop in any part of the gastrointestinal tract, from the esophagus to the rectum. It begins when cells in these organs start growing abnormally and form tumors. The disease can spread from its original location to other parts of the digestive system.

  • Pancreatic Cancer

    A cancer that develops in the tissues of the pancreas, an organ located behind the stomach. The disease begins when abnormal cells in the pancreas start to multiply out of control and form a mass. It can develop in different parts of the pancreas, affecting either the cells that produce digestive enzymes or those that produce hormones.

  • Colorectal Cancer

    A cancer that starts in either the colon or the rectum. It typically begins as small, benign clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can develop into cancer. The disease develops gradually, starting in the innermost layer of the colon or rectum and potentially growing through some or all of the other layers.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507148-35-00Protocol code20140346Estimated enrolment154 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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