Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on the Effectiveness and Safety of Cyclophosphamide Monohydrate and Drug Combination for Patients with Persistent or Recurrent Rare Epithelial Ovarian Tumors

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying treatments for persistent or recurrent rare epithelial ovarian tumors. These are specific types of ovarian cancer that have returned or continued despite treatment. The study aims to evaluate the effectiveness and safety of various treatments that are guided by specific biological markers, which are unique characteristics found in the cancer cells. The treatments being tested include several medications: Endoxan (containing cyclophosphamide monohydrate), Inavolisib (also known as GDC-0077), Giredestrant (also known as GDC-9545), Cotellic (containing cobimetinib), Ipatasertib, Lynparza (containing olaparib), Paclitaxel, Verzenios (containing abemaciclib), Kadcyla (containing trastuzumab emtansine), Avastin (containing bevacizumab), and Tecentriq (containing atezolizumab). Some participants may receive a placebo, which is a substance with no active medication.

The purpose of the study is to determine how well these treatments work in shrinking or controlling the tumors, as well as to assess their safety. Participants will receive one of the treatments based on the specific characteristics of their cancer. The study will monitor the response of the tumors to the treatment and any side effects experienced by the participants. The study is designed to last for a certain period, during which participants will have regular check-ups and tests to track their progress.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatments affect their cancer. The results of this study will help in understanding which treatments are most effective for these rare types of ovarian cancer and could lead to better treatment options in the future.

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

    Joining the study

    Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

    A representative tumor specimen is required for testing to determine the appropriate treatment group.

  2. Step 2

    Treatment assignment

    Based on the results of the tumor specimen testing, assignment to a specific treatment group occurs. Each group receives a different combination of medications tailored to the specific characteristics of the tumor.

  3. Step 3

    Medication administration

    The treatment involves various medications, which may include oral tablets or intravenous infusions. The specific medications and their administration routes are determined by the assigned treatment group.

    Medications such as cyclophosphamide monohydrate, inavolisib, giredestrant, cobimetinib, ipatasertib, olaparib, paclitaxel, letrozole, abemaciclib, trastuzumab emtansine, palbociclib, bevacizumab, and atezolizumab are used in various combinations.

    The dosage, frequency, and duration of each medication depend on the specific treatment protocol.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring of health status and response to treatment is conducted. This includes physical examinations, imaging tests, and laboratory tests.

    The primary goal is to evaluate the effectiveness of the treatment based on the objective response rate, as well as to monitor for any adverse effects.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment regimen, a final evaluation is conducted to assess the overall response to the therapy.

    Long-term follow-up may be necessary to monitor health status and any potential late effects of the treatment.

Who can join the trial?

8 criteria

  • The patient must have **persistent or recurrent epithelial ovarian cancer**. This means the cancer has either not gone away or has come back after treatment.
  • The cancer must be one of the following types: low-grade serous ovarian cancer, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma, or small cell carcinoma of the ovary, hypercalcemic type. It should not be a primary gastrointestinal carcinoma.
  • The disease should not be treatable with surgery that can cure it.
  • The patient must have **measurable disease**. This means there is at least one tumor that can be measured to see if it changes in size during the study.
  • The patient should have had **previous treatment** with one to four different therapies, and at least one of these treatments must have included a **platinum-based drug**. Hormonal therapy is not counted as one of these treatments.
  • The patient must have **platinum-resistant disease**, which means the cancer got worse during or within 6 months after the last platinum treatment. However, patients whose cancer did not respond at all to the first platinum treatment are not eligible.
  • A sample of the patient's tumor must be available for special tests to help decide the treatment plan and for a central review by pathologists.
  • The patient must be female.

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate in the study.
  • Patients who do not have **Persistent or Recurrent Rare Epithelial Ovarian Tumors** cannot participate in the study.
  • Patients who are not within the specified age range cannot participate in the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Biomarker-Driven Therapies are treatments that are selected based on specific biological markers found in a patient's tumor. These markers can help doctors choose the most effective therapy for each individual. In this trial, the therapies are being tested for their ability to treat rare types of ovarian tumors that have either persisted or come back after initial treatment. The goal is to see how well these therapies work and how safe they are for patients.

What is already known about the treatment

Biomarker-Driven Therapy – This treatment is administered to patients with persistent or recurrent rare epithelial ovarian tumors, typically through intravenous infusion or oral tablets, depending on the specific drug used. It is currently being studied in a Phase II clinical trial to assess its effectiveness and safety. The main therapeutic indication is for ovarian tumors that are rare and have not responded to standard treatments. The therapy works by targeting specific biomarkers associated with the cancer cells, disrupting their growth and survival at the molecular level. It falls under the pharmacological classification of targeted cancer therapies, which aim to interfere with cancer cell proliferation by focusing on molecular and cellular changes specific to the tumor.

Investigated diseases

Persistent or Recurrent Rare Epithelial Ovarian Tumors – These are uncommon types of ovarian tumors that originate from the epithelial cells lining the ovary. They are characterized by their persistence or recurrence after initial treatment. The disease often progresses slowly, with symptoms that may include abdominal pain, bloating, and changes in bowel habits. Over time, these tumors can grow and potentially spread to nearby tissues or organs. The progression of the disease can vary significantly among individuals, with some experiencing more aggressive growth than others. Monitoring and management are crucial to understanding the disease's behavior and impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508194-89-00Protocol codeWO42178Estimated enrolment108 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.