Clinical trial · Interventional
Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With Platinum Sensitive Relapsed Ovarian Cancer Who Are in Complete or Partial Response Following Platinum Based Chemotherapy and Whose Tumours Carry Loss of Function Somatic BRCA Mutation(s) or Loss of Function Mutation(s) in Tumour Homologous Recombination Repair -Associated Genes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study is unlikely to be feasible given the evolving ovarian cancer landscape and alternative studies have the potential to meet future clinical demand.
Summary
Brief summary (as posted)
Olaparib administered as monotherapy in the maintenance setting improves progression free survival compared to placebo in patients whose tumours carry loss of function (deleterious or suspected deleterious) somatic BRCA mutations or loss of function (deleterious or suspected deleterious) mutation in non-BRCA Homologous Recombination Repair (HRR) -associated genes who have a complete or partial response to platinum-based chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum Sensitive Relapsed Ovarian Cancer | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OLAPARIB | Drug | Olaparib | ALIAS |
| PLACEBO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1/OLAPARIB
- description
- olaparib 300 mg oral tablets; twice daily
- interventionNames
- Drug: OLAPARIB
- type
- PLACEBO_COMPARATOR
- label
- 2/PLACEBO
- description
- placebo matching olaparib 300 mg oral tablets; twice daily
- interventionNames
- Drug: PLACEBO
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) using modified RECIST 1.1 in the cohort of patients with sBRCA ovarian cancer
- timeFrame
- From date of randomization until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 40 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 96 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be ≥ 18 years of age * Histologically diagnosed relapsed high grade epithelial ovarian cancer (including primary peritoneal and/ or fallopian tube cancer) * Documented deleterious or suspected deleterious somatic BRCA 1 and/or BRCA 2 somatic mutation or evidence of non- BRCA HRR-associated gene mutation in the tumour. * At least 2 previous lines of platinum containing therapy prior to randomisation. * CA-125 measurements prior to randomised treatment * Patients must have normal organ and bone marrow function measured within 28 days of randomisation * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Postmenopausal or evidence of non-childbearing status for women of childbearing potential * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations * Provision of a blood sample for cfDNA biomarker analysis in Pre-Screening Part 1 * Formalin fixed, paraffin embedded (FFPE) tumour sample from the primary or recurrent cancer must be available for central testing. If archival tumour sample is not available tumour sample from fresh biopsy is acceptable, for all patients eligible to participate in Pre-Screening part 2. Exclusion Criteria: * Documented germline mutation in BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). * Patients who have had drainage of their ascites from the final 2 cycles of their last chemotherapy regimen prior to randomisation on the study * Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation * Any previous treatment with a PARP inhibitor, including olaparib * Patients with a known hypersensitivity to olaparib or any of the excipients of the product * Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply) * Patients receiving any systemic chemotherapy (including chemotherapy received as the most recent anticancer therapy) or radiotherapy (except for palliative reasons) within 3 weeks prior to study randomised treatment * Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) CTCAE grade 2) caused by previous cancer therapy, excluding CTCAE grade 2 peripheral neuropathy * Patients with myelodysplastic syndrome/acute myeloid leukaemia (t-AML) or with features suggestive of MDS/AML * Patients with symptomatic uncontrolled brain metastases * Major surgery within 2 weeks of starting study randomised treatment and patients must have recovered from any effects of any major surgery * Patients considered a poor medical risk
References
Publications (0)
Data not yet available