Printed from Voxsanity (voxsanity.com.au) — NCT07694427 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Ovarian Cancer Trial, Not Yet Recruiting
NCT07694427
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are at least 18 years old and meet the legal age of consent where the study is taking place.
- People who have been newly diagnosed with Stage III or IV ovarian, primary peritoneal, or fallopian tube cancer, confirmed by tissue testing to be a specific type (high grade serous, high grade endometrioid, clear cell carcinoma, carcinosarcoma, or mixed histology).
- People who have completed their first round of platinum-based chemotherapy (various types of regimens are acceptable, including with bevacizumab, and alternative medicines may be allowed if there is a history of allergy to standard drugs — confirm with trial site).
- People whose cancer responded to first-line treatment in one of the following ways: complete response, partial response, no evidence of disease, or stable disease, as assessed by the treating doctor.
- People who are able to start the study treatment within 9 weeks of their last dose of first-line chemotherapy.
- People who are planning to receive bevacizumab and have already received at least the required number of bevacizumab cycles as part of their front-line chemotherapy (confirm with trial site for the specific number).
- People who have provided a tissue sample sufficient for a specific genetic repair test called HRD testing (or have had this done locally), with results available before the start of the trial.
- People who are able to provide a suitable tumour tissue sample from their most recent procedure, from an area that has not been previously treated with radiation.
- People who are willing to use adequate contraception as required by local guidelines for clinical study participants.
- Women who are not pregnant or breastfeeding, and who either cannot become pregnant or who are using a highly effective form of contraception (failure rate less than 1% per year) starting at least 30 days before the first study dose, throughout the study, and for at least 8 months after the last dose, and who agree not to donate eggs during this period.
- Women who could become pregnant must have a negative pregnancy test (urine or blood, depending on local requirements) within 24 hours before the first study dose.
- People who are able to understand and sign an informed consent form and follow study requirements.
- People with a performance status score of 0 or 1 on the ECOG scale, meaning they are either fully active or have minor restrictions in physically strenuous activity but can carry out light work (confirm with trial site).
- People whose organs (such as liver, kidneys, and blood cells) are functioning at an adequate level.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose ovarian cancer is linked to a BRCA1 or BRCA2 gene mutation (inherited or acquired), or whose cancer shows signs of a specific type of DNA repair problem called homologous repair deficiency.
- People who have had another cancer (other than the one being studied) that has been active or required treatment within the past 3 years, with some exceptions such as certain skin cancers or in-situ cancers that have been fully removed with no spread.
- People for whom a specific type of maintenance therapy called a PARP inhibitor has been identified as an appropriate treatment option by the principal investigator.
- People who have had a bone marrow transplant (either from a donor or their own cells) or any other organ transplant at any time in the past.
- People who have a known sensitivity or allergy to the study drug or its ingredients that the investigator believes would make participation unsafe.
- People who have untreated brain or central nervous system (CNS) spread of cancer, or brain/CNS spread that has been getting worse (note: people with previously treated and currently stable brain/CNS spread who have not needed steroid treatment for at least 14 days may still be eligible — confirm with trial site).
- People who currently have, or have a history of, a lung condition called interstitial lung disease or non-infectious pneumonitis (lung inflammation).
- People who still have side effects from previous treatment that have not improved to a mild level or returned to their pre-treatment state, with some exceptions such as hair loss, hearing loss, skin pigment changes, hormone conditions managed with replacement therapy, or moderate nerve-related symptoms.
- People with serious or unstable medical conditions (including infections), serious psychiatric conditions, or laboratory results that could affect their safety or ability to participate in the study.
- People with significant wound healing problems or wounds that have not fully healed.
- People with a history of a hole forming in the bowel (gastrointestinal perforation), an abnormal connection between the windpipe and oesophagus, or any severe fistula; or who have had a bowel fistula, internal fistula, or abdominal abscess within 6 months before starting the study; or who have a condition called osteonecrosis of the jaw (bone damage in the jaw).
- People who have signs that the cancer has spread to the area between the rectum and sigmoid colon, or who have symptoms or scan findings suggesting bowel blockage.
- People who have had significant bleeding symptoms, a high tendency to bleed, or bleeding tumours within 30 days before starting the study.
- People who have an inherited or acquired bleeding disorder, or who have had significant coughing up of blood (more than 2.5 mL of red blood) within the past 3 months before starting the study.
- People who have had major surgery within 28 days, or targeted radiation therapy within 21 days, before starting the study.
- People who have received chemotherapy or other anti-cancer drugs (including hormone therapy, targeted therapy, immunotherapy, or biological therapy) within 30 days or 5 half-lives (whichever is shorter) before starting the study, or who would need to continue these during the study — except for maintenance bevacizumab.
- People who have received an experimental treatment as part of another clinical trial within 30 days before starting the study.
- People who have previously received a specific prior therapy (confirm with trial site, as the criterion in the source document is incomplete).
- People who have received certain medicines that affect specific drug transport proteins in the body (P-gp, BCRP, or OATP 1B1/1B3 inhibitors within 7 days, or P-gp inducers within 14 days) before starting the study.
- People who have received a live vaccine within 30 days of starting the study (note: mRNA and adenoviral COVID-19 vaccines are not considered live vaccines).
- People who have received a blood transfusion or blood-stimulating injections (such as G-CSF, GM-CSF, or erythropoietin) within 14 days before starting the study.
- People with a known HIV infection who also meet at least one of a number of additional conditions related to HIV control, CD4 cell counts, treatment changes, or history of HIV-related lymphoma (confirm specific sub-criteria with trial site).
- People with liver enzyme (ALT) levels more than 2.5 times the upper limit of normal, or more than 5 times the upper limit of normal if the cancer has spread to the liver.
- People with total bilirubin (a liver marker) more than 1.5 times the upper limit of normal, unless they have a condition called Gilbert's syndrome and their direct bilirubin level is within an acceptable range.
- People with cirrhosis or currently unstable liver or bile duct disease, as assessed by the investigator, based on signs such as fluid in the abdomen, confusion, clotting problems, low protein, vein swelling in the oesophagus or stomach, or ongoing jaundice (some exceptions may apply — confirm with trial site).
- People who test positive for the Hepatitis B surface antigen at screening, unless they meet specific criteria related to antiviral treatment, undetectable Hepatitis B virus levels, and negative Hepatitis D testing (confirm with trial site).
- People who test positive for a Hepatitis B antibody called HBcAb at screening, unless they have undetectable Hepatitis B virus levels and a negative Hepatitis B surface antigen result.
- People who test positive for Hepatitis C antibodies at screening, unless a follow-up test confirms the infection has fully resolved.
- People with a specific heart rhythm measurement (QTcF) greater than 470 milliseconds on an ECG.
- People with a significant or uncontrolled heart condition in the past 12 months, including a recent heart attack, severe heart failure (Class III or IV), or a significant abnormal heart rhythm not controlled by standard treatment.
- People whose heart pumping function (left ventricular ejection fraction) is below 50% or below their institution's lower limit of normal.
- People with significantly abnormal blood pressure, inadequately treated or uncontrolled high blood pressure, a history of hypertensive crisis or hypertensive brain condition, or who have had their blood pressure medications adjusted due to poor control within 14 days before starting the study.
- People with active kidney conditions such as infection, need for dialysis, or other significant kidney problems that could affect their safety (successfully managed kidney obstruction is permitted).
- People with a history of nephrotic syndrome (a kidney condition causing significant protein loss) or severe proteinuria (Grade 3).
- People who have a high level of protein in their urine at screening, specifically those with 2+ or more on a urine dipstick test and more than 1 gram of protein found in a 24-hour urine collection.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 877-379-3718
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
9 October 2026
Est. completion
6 September 2029
Primary endpoints
Progression Free Survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.