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Azenosertib versus drug combination in platinum‑resistant high‑grade serous ovarian, fallopian tube or primary peritoneal cancer

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

A clinical investigation is being conducted in people with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer that show Cyclin E1 protein expression. The new oral medication being tested is Azenosertib, while the comparison treatments are standard chemotherapy drugs given by IV (into a vein), including topotecan, gemcitabine, doxorubicin, and paclitaxel. Chemotherapy is a type of medicine that tries to stop cancer cells from growing.

The purpose of the study is to determine whether the new drug can keep the cancer from growing for a longer time than the usual chemotherapy options. Participants are randomly placed into one of two groups, meaning the assignment is made by chance rather than choice, and receive either the oral tablets of the test drug or one of the IV chemotherapy choices selected by the doctor. Treatment cycles are given every few weeks, and patients undergo regular blood tests, imaging scans, and symptom checks to track how the disease behaves.

The study continues until the cancer shows signs of getting worse, known as progression, or until side effects become too severe to keep treatment safe. Side effects are any unwanted changes in health that may occur because of the medication, and they are closely monitored by the medical team. Throughout the trial, participants receive standard supportive care to help manage any symptoms related to the disease or its treatment.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After joining the study you are assigned by chance to receive either the test drug azenoseritb or the investigator's choice of chemotherapy.

    The assignment is open label, meaning you and the study staff will know which treatment you receive.

  2. Step 2

    Baseline assessments

    You will undergo a series of initial evaluations that include medical history, physical examination, blood tests, and imaging scans to document the status of the cancer before treatment starts.

    These assessments create a reference point for later comparison of how the disease responds to therapy.

  3. Step 3

    Antiemetic prophylaxis

    If you are assigned to a chemotherapy regimen, you will receive the anti‑nausea medication akynzeo (300 mg of palonosetron and 0.5 mg of netupitant) by mouth before each chemotherapy infusion to help prevent nausea and vomiting.

  4. Step 4

    Start study medication

    If you receive the test drug, you will take one oral tablet of azenoseritb containing 400 mg once daily as directed by the study physician.

    If you receive chemotherapy, you will receive an intravenous infusion of one of the following agents at the listed dose:

    topotecan 4 mg per square meter of body‑surface area,

    gemcitabine 1000 mg per square meter,

    doxorubicin 40 mg per square meter,

    Or paclitaxel 80 mg per square meter.

    The infusion is given through a vein according to the schedule chosen by the investigator.

  5. Step 5

    Treatment cycles

    The assigned medication is given repeatedly in cycles; each cycle continues until the study protocol indicates it should stop, typically when disease progression is observed or side effects become unacceptable.

    The exact length of each cycle follows the standard practice for the selected drug and is determined by the investigator.

  6. Step 6

    Monitoring visits

    Regular visits are scheduled to check your health, including blood tests, physical examinations, and imaging scans to assess tumor size.

    Questionnaires about abdominal symptoms, overall quality of life, and other health aspects are completed during these visits.

    The investigator evaluates progression‑free survival and overall survival based on these data.

  7. Step 7

    Manage side effects

    If you experience side effects, the study team may temporarily stop (dose interruption) or reduce the amount of medication (dose reduction) according to safety guidelines.

    In cases of severe toxicity, permanent discontinuation of the study drug may be required.

  8. Step 8

    End of treatment and follow‑up

    Treatment ends when the disease progresses, unacceptable toxicity occurs, or the study period concludes.

    After stopping the study medication, you will continue to be followed for survival outcomes and any long‑term effects.

Who can join the trial?

11 criteria

  • Provide a recent preserved tumor sample, either the latest tissue block taken within the past three years or 15 fresh slides cut from such a block; this sample is needed for laboratory testing (FFPE means the tissue was fixed in formalin and embedded in paraffin to keep it stable).
  • Have previously received the drug mirvetuximab if it is approved and available for you.
  • Show that your blood and organ health are adequate during the screening period; this means your blood counts and liver/kidney function must be within normal limits.
  • Sign the main Informed Consent Form (ICF), which confirms you understand the study and agree to take part.
  • Be a female who is at least 18 years old (or the legal adult age in your country) at the time you sign the consent form.
  • Have an ECOG performance status score of 0 or 1, indicating you are fully active or able to carry out light work.
  • Have a diagnosis of high‑grade serous ovarian, fallopian tube, or primary peritoneal cancer confirmed by looking at the cells under a microscope (histology or cytology).
  • Have at least one tumor that can be measured on scans, as defined by the standard measurement rules called RECIST v1.1.
  • Have tumor tissue that tests positive for the protein cyclin E1 using a laboratory test that has been approved by the study sponsor.
  • Have cancer that is considered platinum‑resistant, meaning it no longer responds to platinum‑based chemotherapy.
  • Have received between one and three previous treatment courses (called “lines of therapy”), or up to four if you have already taken mirvetuximab.

Who cannot join the trial?

13 criteria

  • Platinum refractory disease in front‑line therapy – meaning the cancer did not respond to the first treatment that contains platinum‑based drugs.
  • Having tumor types such as endometrioid, clear cell, mucinous, sarcomatous histology, mixed tumors that contain any of these, or low‑grade or borderline ovarian tumors – these are different forms of ovarian cancer that are not allowed.
  • Any of the following recent treatments or procedures:
    • Hospitalization for any reason within the past 14 days.
    • Major surgery within the past 28 days or any planned major surgery during the study period.
    • Any chemotherapy (drug treatment that kills cancer cells) or targeted tumor therapy within the past 21 days or within five drug half‑lives.
    • Radiation therapy within the past 21 days (except if the radiation covered ≤5% of the bone marrow, the patient may still be eligible).
    • Autologous or allogeneic stem cell transplant (using the patient’s own cells or a donor’s cells) within the past 3 months.
    • Current use of any other investigational drug (experimental medicine) within the past 28 days or five half‑lives.
    • Inability to stop taking prescription or non‑prescription medicines that the study requires to be discontinued.
    • Inability to stop certain foods or herbal supplements at least 14 days before the first dose, or a current or anticipated need for a prohibited therapy, food, or supplement.
    • Prior treatment with azenosterib or any other drug that blocks WEE1, ATR, CHK1/2, or PKMYT1 – these are specific types of experimental cancer‑targeting medicines.
    • Having a serious illness or other medical condition listed in the study protocol.
    • Unresolved side effects that are worse than mild (grade > 1) from previous therapies, except for mild nerve problems (neuropathy), hair loss (alopecia), or skin color changes (skin pigmentation).
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Investigated drugs

  • Topotecan

    is a chemotherapy drug given by intravenous infusion. In this study it is used as one of the investigator’s choice chemotherapy options for patients whose cancer has become resistant to platinum‑based treatments. It works by interfering with the cancer cells’ ability to copy their DNA, which can help slow or stop tumor growth.

  • Azenosertib

    (also known by its code names ZN‑c3 or KP‑2638) is an oral medication being tested as the new experimental treatment in this trial. It is taken as a film‑coated tablet. Azenosertib belongs to a class of drugs that target specific proteins involved in repairing DNA damage in cancer cells, aiming to make the tumor cells more vulnerable and improve outcomes for patients with high‑grade serous ovarian, primary peritoneal, or fallopian tube cancers that show cyclin E1 protein.

  • Gemcitabine

    is another chemotherapy drug administered by intravenous infusion. It is included as one of the possible standard chemotherapy choices that the investigators may select for patients in the control group. Gemcitabine works by getting incorporated into the DNA of dividing cells, which stops the cancer cells from growing and dividing.

  • Akynzeo

    is a combination of two oral medicines, palonosetron and netupitant, packed together in hard capsules. It is given to help prevent nausea and vomiting that can be caused by chemotherapy. In this trial, Akynzeo is used as background supportive care to keep patients comfortable during their cancer treatments.

  • Doxorubicin

    is a chemotherapy agent delivered by intravenous infusion. It may be chosen by the investigators as part of the standard chemotherapy regimen for patients in the control arm. Doxorubicin works by intercalating into DNA and generating free radicals, which damages cancer cells and helps to stop their growth.

  • Paclitaxel

    is an intravenous chemotherapy drug that can also be selected by the investigators as the comparator chemotherapy. Paclitaxel stabilizes microtubules inside cells, preventing them from dividing properly, which leads to the death of cancer cells. It is a commonly used treatment for ovarian and related cancers.

What is already known about the treatment

  • Topotecan

    This drug is given by intravenous infusion and is an approved chemotherapy used for ovarian and other solid tumors. It works by blocking an enzyme called topoisomerase I, which stops cancer cells from copying their DNA. It is classified as a topoisomerase inhibitor and is listed in medical literature as a standard treatment option.

  • Azenosertib

    This experimental medication is taken as an oral film‑coated tablet and is currently being studied in clinical trials for platinum‑resistant high‑grade serous ovarian cancer. It blocks a protein called ATR that helps cancer cells repair DNA damage, making them more likely to die. Azenosertib belongs to the class of targeted kinase inhibitors and is not yet approved for general use.

  • Gemcitabine hydrochloride

    Administered by intravenous infusion, gemcitabine is an approved chemotherapy for several cancers, including ovarian cancer. It mimics a building block of DNA and stops cancer cells from making new DNA, which slows their growth. It is classified as an antimetabolite drug and is widely described in medical references as a standard treatment option.

  • Palonosetron

    This anti‑nausea medicine is taken orally in a capsule (as part of a combination product) and is approved to prevent chemotherapy‑induced vomiting. It blocks serotonin receptors in the gut and brain, which reduces the urge to vomit. Palonosetron is classified as a 5‑HT3 receptor antagonist and is well known in clinical practice for its long‑lasting effect.

  • Netupitant

    Also taken orally in a capsule, netupitant is used together with palonosetron to prevent nausea and vomiting after chemotherapy. It works by blocking the NK‑1 (substance P) receptors that trigger vomiting signals. Netupitant belongs to the class of NK‑1 receptor antagonists and is listed in guidelines for anti‑emetic therapy.

  • Doxorubicin hydrochloride

    Given by intravenous infusion, doxorubicin is an approved chemotherapy for many cancers, including ovarian cancer. It slips between DNA strands and blocks an enzyme called topoisomerase II, which stops cancer cells from copying their DNA. It is classified as an anthracycline antibiotic and is a well‑established drug in oncology literature.

Investigated diseases

High‑grade serous ovarian, fallopian tube, or primary peritoneal carcinoma - This cancer begins in the lining of the ovary, the fallopian tube, or the surface of the abdominal cavity. It typically grows rapidly and spreads to nearby tissues within the pelvis and abdomen. As it expands, it can involve the lining of the abdomen, lymph nodes, and sometimes distant organs. The disease often progresses by increasing tumor size and causing fluid buildup in the abdomen.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524641-27-00Protocol codeZN-c3-020Estimated enrolment420 patientsSponsorK-Group Beta Inc.

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