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NCT04742075

NCT04742075
Active, Not Recruiting Phase 2

Who may be able to join

Who might be able to join this trial:

  • You are able to understand and sign a consent form before joining the trial
  • You have been diagnosed (confirmed by tissue sample) with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer — but not the mucinous or low-grade serous types
  • Your cancer has come back (shown by scans or tissue sample) at least 6 months after your second-to-last chemotherapy treatment
  • You do not carry certain inherited or tumour-related BRCA gene mutations (confirm with trial site)
  • You have had at least 2 but no more than 3 rounds of chemotherapy overall, meaning you are at your first or second relapse, with a gap of more than 6 months since your second-to-last chemotherapy
  • You have completed at least 4 cycles of your most recent platinum-based chemotherapy
  • You have either never received a PARP inhibitor (a type of targeted cancer drug), or you have taken one but your cancer did not progress within the first 6 months of taking it
  • Your cancer did not get worse during or after your most recent platinum-based chemotherapy (your scans show complete response, partial response, stable disease, or no sign of disease)
  • You agree to have a test to check a specific feature of your tumour called HRD (confirm with trial site for accepted tests)
  • You are able to start the trial within 10 weeks of finishing your last platinum-based chemotherapy
  • You are 18 years of age or older
  • You weigh more than 30 kg
  • You are generally well enough to carry out light daily activities (confirm with trial site what this means in practice)
  • Your life expectancy is at least 16 weeks
  • Your blood, liver, and kidney test results are within acceptable ranges, checked within the last 28 days (confirm exact values with trial site)
  • You are able to swallow tablets whole, without chewing, breaking, or crushing them
  • You are post-menopausal, or if you could become pregnant, you have a negative pregnancy test within 28 days of starting treatment and are using an approved method of contraception

Who may not be able to join:

  • You have previously been treated with immune checkpoint inhibitor drugs (a type of immunotherapy) — though if you took part in a blinded trial where you may or may not have received one, you may still be eligible (confirm with trial site)
  • You have had another cancer in the last 5 years, unless it was certain early-stage or skin cancers that were fully treated (confirm with trial site)
  • You have certain serious, uncontrolled heart problems or a heart condition you were born with affecting heart rhythm
  • You have or have had a blood cancer called myelodysplastic syndrome or acute myeloid leukaemia, or show signs of these conditions
  • You have brain metastases (cancer that has spread to the brain) that are causing symptoms and are not controlled; or you have spinal cord compression that has not been definitively treated with at least 28 days of stable disease
  • You have a serious uncontrolled medical condition or active uncontrolled infection (such as recent heart attack, severe seizures, or serious lung disease)
  • You are currently being treated with a drug called bevacizumab and have received it within the last 3 weeks
  • You are currently receiving any other cancer treatment, or taking more than 10 mg per day of prednisolone (a steroid) on an ongoing basis
  • You are currently taking certain medications that strongly or moderately affect how the study drug is processed by your body (confirm with trial site for the specific drug names), unless you have stopped taking them for the required time beforehand
  • You have previously had a bone marrow or umbilical cord blood transplant from a donor
  • You have had major surgery or a serious injury within the last 28 days
  • You are known to be HIV positive, or have active hepatitis B or C infection (certain resolved hepatitis B or C cases may still be eligible — confirm with trial site)
  • You are pregnant, breastfeeding, planning to become pregnant during the study, or within 1 month after your last dose of the study drug; or you are not using an approved method of contraception if you could become pregnant
  • You have taken part in another clinical trial within the last 28 days, or within 5 half-lives of that trial's drug — which

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
Active, Not Recruiting
Phase
Phase 2
Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Registry
clinicaltrials_gov
Start date
15 December 2021
Est. completion
1 May 2026

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Progression-free survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov