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Study of catequentinib (AL3818) combined with platinum chemotherapy for patients with recurrent or metastatic ovarian, fallopian tube, or primary peritoneal cancer

Verified siteInvestigationalNo 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 studies the effectiveness of adding catequentinib (also known as AL3818) to standard platinum-based chemotherapy in treating platinum-resistant recurrent or metastatic ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. Catequentinib is a type of drug called a receptor tyrosine kinase inhibitor, which works by blocking certain proteins that help cancer cells grow.

The main purpose of this research is to determine if adding catequentinib to standard chemotherapy improves how long patients live without their cancer getting worse. The medication is taken by mouth in the form of capsules, with different dose levels being tested. During the study, participants will receive either catequentinib combined with standard chemotherapy or standard chemotherapy alone.

The study will track how well tumors respond to treatment, how long any improvements last, and how long patients survive overall. Doctors will use special imaging tests called CT or MRI scans to measure if tumors are shrinking or growing. The total duration of treatment may continue for up to 336 days, depending on how well patients respond and tolerate the medication.

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

    A medical assessment will be performed to confirm your eligibility for the study

    Tests will include CT or MRI scan to measure your condition

    Basic health checks will evaluate your bone marrow, kidney, and liver function

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups

    Group 1: catequentinib dihydrochloride capsules combined with standard chemotherapy

    Group 2: standard chemotherapy alone

  3. Step 3

    Treatment period

    The medication will be taken by mouth in capsule form

    Regular medical check-ups will monitor your health status

    Imaging scans will be performed to track changes in your condition

    Treatment continues until signs of disease progression or other stopping criteria

  4. Step 4

    Follow-up evaluations

    Regular assessments will track your response to treatment

    Imaging scans will be reviewed by independent medical experts

    Your overall health status will be monitored throughout the study period

    The study is expected to continue until February 2025

  5. Step 5

    Safety monitoring

    Your health will be closely monitored throughout the study

    Regular blood tests will check your body functions

    Any side effects or health changes should be reported to the study team

Who can join the trial?

15 criteria

  • Must be a female aged 18 years or older
  • Must have a confirmed diagnosis of ovarian, fallopian tube, or primary peritoneal cancer that is either:
    • Platinum-resistant (cancer that progressed within 6 months after platinum chemotherapy) with at least two prior treatments
    • Platinum-refractory (cancer that progressed during first platinum chemotherapy) with at least one prior treatment
    • Must have measurable cancer that can be seen on CT or MRI scan
    • Must have a life expectancy of at least 3 months
    • Must be able to take medications by mouth
    • Must have adequate:
      • Blood cell counts
      • Kidney function
      • Liver function
      • Blood clotting function
      • Must have good physical ability (ECOG performance status of 2 or better, meaning able to care for self but unable to work)
      • If able to become pregnant, must:
        • Use birth control starting 1 week before treatment until 4 weeks after last treatment
        • Have a negative pregnancy test within 28 days before starting
        • Must provide written informed consent
        • Must be willing and able to follow all study requirements and follow-up procedures

Who cannot join the trial?

13 criteria

  • History of allergic reactions to similar medications used in the study
  • Active brain metastases (cancer that has spread to the brain) that are not treated or stable
  • Significant heart problems including:
    • Uncontrolled high blood pressure
    • Heart attack within the past 6 months
    • Unstable heart rhythm problems
    • Severe liver or kidney problems
    • Active bleeding or high risk of bleeding complications
    • Current participation in other clinical trials or treatment with experimental drugs within the past 30 days
    • Major surgery within the past 4 weeks
    • Pregnant or breastfeeding women
    • Unable to swallow oral medications
    • Active, uncontrolled infections requiring treatment
    • Any other serious medical condition that could interfere with study participation or interpretation of results
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Investigated drugs

  • Anlotinib

    (also known as AL3818 or Catequentinib) is a medication that works by blocking specific proteins called tyrosine kinases. These proteins are involved in cancer cell growth and survival. The medication is designed to help stop or slow down the growth of cancer cells when used together with standard chemotherapy treatments.

  • Platinum-based chemotherapy

    is a standard type of cancer treatment that uses platinum-containing drugs to kill cancer cells. This type of chemotherapy is commonly used to treat various types of cancers, including endometrial, ovarian, fallopian tube, and cervical cancers. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing.

What is already known about the treatment

Catequentinib (Anlotinib) – A dual receptor tyrosine kinase inhibitor administered orally that is being investigated in clinical trials for the treatment of platinum-resistant recurrent or metastatic ovarian, fallopian, and primary peritoneal cancers. The medication works by blocking specific proteins called tyrosine kinases, which are involved in cancer cell growth and blood vessel formation, thereby potentially slowing down or stopping tumor growth. It is currently being studied in combination with standard platinum-based chemotherapy to evaluate its safety and effectiveness in treating various gynecologic cancers, with progression-free survival being the primary measure of its efficacy.

Investigated diseases

  • Ovarian Cancer

    A disease that begins in the ovaries, which are the female reproductive organs that produce eggs. The cancer cells can grow and multiply uncontrollably, forming tumors in the ovaries. Over time, cancer cells can spread to the fallopian tubes, peritoneum (the lining of the abdomen), and other parts of the body. When cancer returns after initial treatment, it is called recurrent ovarian cancer.

  • Fallopian Tube Cancer

    A rare cancer that develops in the fallopian tubes, which are the ducts that connect the ovaries to the uterus. The cancer begins when cells in the fallopian tubes start to grow abnormally and form tumors. These cancer cells can spread to nearby organs and other parts of the body.

  • Primary Peritoneal Cancer

    A cancer that develops in the peritoneum, which is the thin layer of tissue that lines the abdomen and covers most organs in the abdominal cavity. The cancer cells grow and multiply in the peritoneal lining, forming tumors. This type of cancer behaves similarly to ovarian cancer and can spread throughout the abdominal cavity.

Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516166-11-00Estimated enrolment220 patientsSponsorAdvenchen Laboratories LLC

sourced from the EU Clinical Trials Register and site verification

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