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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT07044349
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 willing to give their consent to participate and are able to follow the trial schedule, including visits, treatments, and tests.
- Women aged 18 or older at the time of signing the consent form.
- People who have been diagnosed by a pathologist with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- People who have at least one tumour that can be measured using standard imaging guidelines (RECIST v1.1).
- People whose cancer has come back or gotten worse while on platinum-based chemotherapy, or within 6 months after their last platinum-based treatment — this must be confirmed by imaging, not just by blood marker changes.
- People who have received at least 1 but no more than 3 prior lines of systemic cancer treatment, and whose cancer has not responded adequately to, or who could not tolerate, existing standard treatments (maintenance therapies such as bevacizumab, PARP inhibitors, or hormone therapy count as part of a prior line of treatment).
- People with a general health status rated as 0 or 1 on the ECOG scale, meaning they are either fully active or have minor restrictions but are able to carry out light work.
- People whose recent blood count results (taken within 7 days before enrolment, without the use of certain blood-boosting medications in the 14 days before the test) show: a neutrophil count of at least 1.5 × 10⁹/L, a platelet count of at least 100 × 10⁹/L, and haemoglobin of at least 9.0 g/dL.
- People whose recent blood chemistry results (taken within 7 days before enrolment) show liver and kidney function within acceptable ranges, including bilirubin, liver enzymes (ALT and AST), and kidney filtration rate (confirm specific values with trial site).
- People who are expected to live for at least 12 weeks.
- Women who could become pregnant must agree to use highly effective contraception and not donate eggs during the study and for 8 weeks after the last dose, must have a negative pregnancy test at screening, and must be willing to have further pregnancy tests during the study.
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 cancer got worse during or within 3 months of completing their first round of platinum-based treatment.
- People who have had another cancer in the past 5 years, except for certain cured skin cancers, cervical carcinoma in situ, or papillary thyroid carcinoma.
- People who have received anti-cancer treatments such as chemotherapy, radiation, targeted therapy, or immunotherapy within 4 weeks before the first dose of the trial drug (with some exceptions for specific drug types — confirm with trial site).
- People who have received a specific type of chemotherapy drug (nitrosourea or mitomycin C) within 6 weeks before the first dose of the trial drug.
- People who have taken certain oral cancer medications (oral fluorouracil, small molecule targeted drugs, or hormone therapy) within 2 weeks or within 5 half-lives of the drug before the first dose, whichever is shorter.
- People who have used traditional Chinese medicines with anti-cancer properties, or hormone therapy, within 2 weeks before the first dose.
- People who have had major surgery or a serious injury within 4 weeks before the first dose, or who are expected to need planned surgery during the study.
- People who still have significant side effects from previous cancer treatments that have not improved to a mild level (with some exceptions such as hair loss).
- People who have had a hole or tear in the bowel, an abdominal abscess, bowel bleeding, or bowel blockage, or who have had signs of bowel obstruction within 3 months before the first dose.
- People who are unable to swallow or absorb oral medications, or who require feeding entirely through a drip into a vein.
- People who need to take certain medications that strongly interact with a liver enzyme called CYP3A4, or medications that affect heart rhythm, within 14 days before the first dose or during the study (confirm specific medications with trial site).
- People who have brain or spinal cord metastases that are causing symptoms or are not under control, including those whose brain metastases have progressed within 2 months of radiation or local treatment.
- People who have bone metastases that are not under control, including those at risk of fracture or needing surgery or radiation soon.
- People who have fluid build-up around the lungs, heart, or in the abdomen that requires draining once a month or more often.
- People with a serious history of heart or blood vessel disease, including: a heart attack, severe chest pain, or heart bypass surgery within the past 6 months; significant heart failure; reduced heart pumping function; an abnormal heart rhythm measurement on ECG; a history of heart muscle inflammation (myocarditis); or other serious heart events.
- People who have had a stroke or mini-stroke within the past 6 months, uncontrolled high blood pressure despite treatment, or other high-risk heart conditions as judged by the trial doctor.
- People with uncontrolled diabetes.
- People with active hepatitis B, active hepatitis C, HIV, or syphilis (based on specific test results — confirm with trial site).
- People who had an active infection before screening that required systemic antibiotic, antiviral, or antifungal treatment.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- People with a mental health condition or who are unlikely to be able to follow the study requirements.
- People who have previously been treated with a drug called utidelone.
- People who are known to be allergic to the trial drug or any of its ingredients.
- People who are already taking part in another interventional clinical trial or using another experimental treatment.
- People who the trial doctor considers unsuitable for any other medical or safety reason.
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: 010-56315388
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
Beijing Biostar Pharmaceuticals Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 March 2027
Primary endpoints
Dose-limiting toxicity (DLT) and the maximum tolerated dose of the BID administration regimen; The incidence of adverse events (AE)/serious adverse events (SAE)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 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.