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AZD5335

Clinical trials are investigating AZD5335 in women with advanced platinum-resistant epithelial ovarian cancer. The studies are looking at how well AZD5335 works compared with other treatments, and they also measure safety and disease control. One large phase 3 trial is separating patients by FRα tumor level.

Table of Contents

Trial overview

The clinical trial data available for AZD5335 describe one interventional study, which means patients are assigned to treatment groups by the study team.[1] The study is called TREVI-OC-01 and is listed as Authorised.[1]

This study is testing AZD5335 in people with advanced platinum-resistant epithelial ovarian cancer.[1] Platinum-resistant means the cancer does not respond well to platinum-based treatment, or it returns soon after that treatment.[1]

Who is being studied

The trial is focused on participants with platinum-resistant relapsed ovarian cancer, also described in the record as advanced platinum-resistant epithelial ovarian cancer.[1] The study splits patients into two groups based on FRα expression, which is a tumor marker found on some cancer cells.[1]

  • FRα-high cohort: this group includes people whose tumors have a high level of FRα.[1]

  • FRα-low cohort: this group includes people whose tumors have a low level of FRα.[1]

This means the trial is not studying all ovarian cancer patients in the same way. It is testing whether tumor marker level helps guide which treatment works better.[1]

Treatments being compared

In the FRα-high group, AZD5335 is compared with mirvetuximab soravtansine.[1] This is a direct comparison to see which treatment gives better disease control.[1]

In the FRα-low group, AZD5335 is compared with investigator’s choice chemotherapy.[1] The trial record lists the chemotherapy options as liposomal doxorubicin, paclitaxel, or topotecan.[1]

These comparison treatments are important because they show that the study is asking a practical question: does AZD5335 work better than the current options used for this type of ovarian cancer?[1]

Trial phase and study design

The study is a Phase 3 trial.[1] Phase 3 studies usually involve large numbers of patients and compare treatments to learn how well they work in real clinical use.[1]

The planned enrollment is 1,100 participants.[1] A study of this size can give stronger evidence about whether the treatment helps patients with this cancer type.[1]

Main endpoint and what it means

The main endpoint is progression-free survival (PFS).[1] This is the time from randomization until the cancer gets worse on scans, using RECIST v1.1, or until death from any cause.[1]

RECIST v1.1 is a standard way doctors measure tumor change on imaging scans.[1] In simple terms, the trial is asking how long patients can stay without their cancer growing or worsening.[1]

What this means for patients

For patients, this trial is important because it is testing AZD5335 against treatments already used for platinum-resistant ovarian cancer.[1] The study is also trying to learn whether the amount of FRα on the tumor can help match the right treatment to the right patient.[1]

Because the trial is divided into FRα-high and FRα-low groups, the results may help show whether different patients benefit from different treatment choices.[1] The main outcome measure, PFS, focuses on disease control rather than just whether a treatment can be given.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT07218809Phase 3Advanced platinum-resistant epithelial ovarian cancerAuthorised1100

FAQ

  • What is being studied in AZD5335 trials? The trials are studying whether AZD5335 works better than other treatment options in advanced platinum-resistant ovarian cancer. The main focus is on how long patients live without the cancer getting worse.
  • Who may be able to join these trials? The trial data describe participants with advanced platinum-resistant epithelial ovarian cancer. Some groups are based on FRα tumor expression, which means how much of a tumor marker is found on the cancer cells.
  • What phase is the main AZD5335 trial? The main trial listed is a Phase 3 study. Phase 3 trials compare treatments in larger groups of patients to see how well they work.
  • What treatments is AZD5335 compared with? In the FRα-high group, AZD5335 is compared with mirvetuximab soravtansine. In the FRα-low group, AZD5335 is compared with chemotherapy chosen by the investigator, such as liposomal doxorubicin, paclitaxel, or topotecan.
  • What is the main result the trial measures? The main result is progression-free survival, often called PFS. This means the time from randomization until the cancer grows on scans or the patient dies from any cause.

Ongoing Clinical Trials on AZD5335

  • Comparing AZD5335 with Mirvetuximab Soravtansine or a drug combination in patients with platinum-resistant ovarian cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark France Germany Greece +4

Glossary

  • Advanced cancer: Cancer that has spread or is no longer limited to one small area.
  • Platinum-resistant: A cancer that does not respond well to platinum-based chemotherapy or comes back soon after it.
  • Epithelial ovarian cancer: A common type of ovarian cancer that starts in the cells covering the ovary.
  • FRα: A tumor marker found on some cancer cells. The trial separates patients into FRα-high and FRα-low groups.
  • FRα-high: A higher amount of FRα found on the tumor.
  • FRα-low: A lower amount of FRα found on the tumor.
  • Randomization: A process that assigns patients to a treatment group by chance.
  • Investigator’s choice chemotherapy: Chemotherapy selected by the study doctor from the allowed options in the trial.
  • Progression-free survival (PFS): The length of time after treatment starts before the cancer gets worse or the patient dies.
  • RECIST v1.1: A standard way doctors measure whether a tumor is growing, shrinking, or staying the same on scans.

References