Back to Ovarian Cancer
NCT03783949
NCT03783949
Who may be able to join
Who might be able to join this trial:
- You are a woman aged 18 or older
- You have been diagnosed with a specific type of ovarian, fallopian tube, or primary peritoneal cancer (high-grade serous, high-grade endometrioid, undifferentiated epithelial, or carcinosarcoma types)
- Your cancer came back more than 6 months after your last platinum-based chemotherapy treatment
- Your cancer can be measured or detected on scans (according to standard medical criteria)
- You are in good general health and able to carry out daily activities with little or no limitation (confirm with trial site)
- Your bone marrow is working well enough, shown by blood tests meeting specific levels for platelets and white blood cells
- Your kidneys, liver, and other organs are functioning well enough, as shown by standard blood and urine tests
- Your blood clotting levels are within an acceptable range
- If you are taking steroid medications, your dose has been stable and low for at least 4 weeks before starting the trial
- You are able to swallow and take tablets or capsules by mouth
- A tissue sample from your original ovarian cancer diagnosis is available to be sent to the trial team
- If you could become pregnant, you have a negative pregnancy test within 7 days before starting treatment, and you agree to use highly effective contraception during the study and for 180 days after your last dose
- You agree not to donate blood during the study or for 90 days after your last dose
- You agree not to breastfeed during the study or for 180 days after your last dose
- Your haemoglobin (red blood cell level) is at an acceptable level, and you have not had a blood transfusion in the 4 weeks before starting treatment
Who may not be able to join:
- You have a type of ovarian tumour classed as "borderline" or low malignant potential
- You have had radiotherapy to your pelvis or abdomen, or to a large area of your bone marrow, recently before the trial starts
- You have had surgery (including an open biopsy) within 4 weeks before starting the trial drug, or are expected to need major surgery during the trial
- You have had a minor surgical procedure within 24 hours before your first treatment
- You have a history of certain blood or bone marrow disorders (myelodysplastic syndrome or acute myeloid leukaemia)
- You have a serious uncontrolled medical condition or active infection (for example, uncontrolled heart rhythm problems, a recent heart attack, uncontrolled seizures, or a psychiatric condition preventing you from giving consent)
- You are currently taking high daily doses of aspirin (more than 325 mg per day) or have done so within the last 10 days
- You have been diagnosed with or treated for another cancer within the last 2 years, unless it was certain types of skin cancer or cervical cancer that was fully treated
- You have significant stomach or bowel problems that could increase the risk of bleeding or perforation (such as active ulcers, inflammatory bowel disease, or a history of bowel obstruction in the past year)
- You have a wound or bone fracture that is not healing
- You have active or symptomatic spread of cancer to the brain or the lining of the brain (though you may still be eligible if this was treated and you currently have no symptoms — confirm with trial site)
- Your heart's pumping function is below the normal range for the trial centre
- You have had a stroke, mini-stroke, or bleeding in the brain within the last 6 months
- You have significant heart disease, such as severe heart failure, a heart attack in the past 6 months, unstable chest pain, or certain heart rhythm problems
- You or a family member has a history of a heart condition called prolonged QT syndrome, or your heart's electrical activity shows a prolonged QT interval on an ECG
- You have certain heart rhythm problems requiring specific medications to control them (confirm with trial site)
- You have certain types of heart conduction problems (second- or third-degree AV block without a pacemaker, or complete left bundle branch block)
- You have a history of bleeding disorders, or your cancer involves major blood vessels
- You have taken part in another clinical trial with an experimental treatment within the last 28 days, or are currently in another interventional clinical trial
- You are pregnant or currently breast
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
Universitaire Ziekenhuizen KU Leuven
Registry
clinicaltrials_gov
Start date
30 November 2018
Est. completion
1 September 2023
Where this trial is recruiting
🇦🇹 Austria
🇧🇪 Belgium
🇫🇷 France
🇩🇪 Germany
🇮🇹 Italy
Primary endpoints
Progression-free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.