Printed from Voxsanity (voxsanity.com.au) — NCT06063070 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT06063070
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
- The person is willing and able to sign a consent form and follow the trial's treatment and check-up schedule.
- The person is 18 years of age or older (based on the date the consent form is signed).
- The person has been diagnosed through laboratory testing with a specific type of ovarian, primary peritoneal, or fallopian tube cancer — specifically high-grade serous, medium-low differentiation, or high-grade endometrioid (Grade II or higher); if the tumour is a mixed type, the high-grade serous or high-grade endometrioid part must make up more than 50%.
- The person has been newly diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer classified as Stage III or IV (using the 2018 FIGO system), confirmed by tissue testing, and has undergone tumour reduction surgery.
- The person has completed between 6 and 9 cycles of first-line platinum-taxane chemotherapy before joining — or a minimum of 4 cycles if platinum-based treatment had to be stopped early due to severe side effects; pre-surgery and post-surgery chemotherapy together count as one treatment course.
- Before joining, the person's cancer must be in complete response (CR) or partial response (PR) to first-line treatment, and the trial drug must be started at least 3 weeks but no more than 9 weeks after the last chemotherapy dose.
- At least 4 cycles of platinum-based chemotherapy have been completed.
- During or after platinum-containing chemotherapy, no other investigational drugs or treatments (other than hormonal therapy drugs) were used at the same time.
- The use of bevacizumab alongside first-line platinum-taxane chemotherapy was permitted.
- At the end of the last platinum-containing treatment, imaging showed CR or PR, and a blood tumour marker called CA125 either fell to within the normal range or dropped by 90% or more from pre-treatment levels — and remained stable (within normal range, or not more than 10% higher than the last reading) in the 7 days before the first trial dose.
- If there were no measurable tumour areas before chemotherapy started, CA125 must have returned to within the normal range during treatment and stayed there for the 7 days before the first trial dose.
- The person has a general health and activity level rated 0 or 1 on the ECOG scale (meaning fully active or able to carry out light activity).
- The person does not carry inherited (germline) mutations in the BRCA1 or BRCA2 genes (i.e., both genes are normal/wild-type).
- The person has normal organ and bone marrow function, with specific blood test results meeting required levels — including white blood cell counts, platelet counts, haemoglobin, albumin, liver function markers, kidney function, and bilirubin — and has not received blood products or cell growth factors in the 14 days before the first dose (confirm specific values with trial site).
- The person is postmenopausal or has confirmed non-childbearing status before the first dose of the trial drug (confirm with trial site).
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.
- The person has had another cancer within the past 5 years or currently has an untreated cancer — except for certain skin cancers, cervical carcinoma in situ, or breast cancer with no recurrence more than 3 years after surgery.
- The person has untreated spread of cancer to the brain or surrounding membranes; those who have had prior brain or meningeal metastasis treated with radiotherapy or surgery may still be considered if imaging shows the condition has been stable for at least 1 month, hormone therapy (above a certain dose) was stopped more than 2 weeks ago, and there are no current symptoms (confirm with trial site).
- The person has previously been treated with any PARP inhibitor drug, including olaparib, niraparib, rucaparib, pamiparib, or fluzoparib.
- The person is unable to swallow tablets properly, or has a digestive condition that the trial doctor believes may affect how the drug is absorbed.
- The person has had a bowel obstruction, bowel perforation, or a hole in the digestive tract within the past 3 months.
- The person has fluid build-up in the abdomen or around the lungs causing symptoms that require draining, or has had such fluid drained within the 2 months before the first trial dose.
- The person has significant heart disease that is not well controlled, such as moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, certain heart rhythm problems requiring treatment, or a specific abnormality on a heart tracing test (QTc above 470ms).
- The person has abnormal blood clotting results, a tendency to bleed, or is receiving clot-dissolving or blood-thinning therapy — though low-dose preventive use of certain blood thinners may be permitted (confirm with trial site).
- The person has had significant bleeding episodes or a clear tendency to bleed within the 3 months before the first dose, such as stomach or gut bleeding or ulcers, or has an inflamed blood vessel condition; a positive stool blood test at screening may require further investigation including a camera test of the stomach.
- The person has active ulcers, wounds that have not healed, or bone fractures.
- The person has high blood pressure that cannot be brought under control with medication (systolic at or above 150 mmHg or diastolic at or above 90 mmHg).
- The person has had any bleeding event rated at severity level 2 or higher (on the CTCAE 5.0 scale) within the 4 weeks before the first dose.
- The person has an active infection or an unexplained fever above 38.5°C during the screening period before the first dose.
- The person has an inherited or acquired immune deficiency (such as HIV infection), or has active hepatitis B or hepatitis C based on specific blood test results (confirm with trial site).
- The person has received radiotherapy, chemotherapy, hormonal therapy, or targeted therapy less than 4 weeks before starting the trial drug (or less than 5 half-lives for oral targeted therapies), or still has side effects from previous treatment (other than hair loss) that have not recovered to a mild level (Grade 1 or below on the CTCAE 5.0 scale).
- The person has had a blood clot or stroke-related event — such as a mini-stroke, brain bleed, brain infarction, deep vein blood clot, or lung blood clot — within the 6 months before the first dose.
- The person has an inherited or acquired bleeding or clotting disorder (such as haemophilia, a clotting disorder, or low platelet levels), or has had significant bleeding within the 3 months before the first dose.
- The person is receiving other systemic cancer treatments during the study period.
- In the trial doctor's judgement, the person has other factors that may make it necessary to stop the study early, such as other serious illnesses (including mental health conditions), major abnormal test results, or personal or social circumstances that could affect safety or the ability to collect information and samples.
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: 18928806306
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
18 October 2023
Est. completion
31 January 2025
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-free Survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 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.