Phase 3
Completed N=279
Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients
Source: ClinicalTrials.gov NCT03402841 ↗Enrolled (actual)
279
Serious AEs
20.8%
Results posted
Oct 2021
Primary outcomePrimary: Progression Free Survival (PFS) — 9.2 months
◆ Published Evidence
Established
57citations · ~14 / year
Olaparib maintenance monotherapy in platinum-sensitive relapsed ovarian cancer patients without a germline BRCA1/BRCA2 mutation: OPINION primary analysis.
Summary
The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy
Linked Publications (3)
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Olaparib maintenance monotherapy in platinum-sensitive relapsed ovarian cancer patients without a germline BRCA1/BRCA2 mutation: OPINION primary analysis.
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Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib.
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Olaparib maintenance monotherapy in platinum-sensitive, relapsed ovarian cancer without germline <i>BRCA</i> mutations: OPINION Phase IIIb study design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
9.2 | — |
| SECONDARY Time to First Subsequent Therapy or Death (TFST) |
13.9 | — |
| SECONDARY Time to Treatment Discontinuation or Death (TDT) |
9.6 | — |
| SECONDARY PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status |
11.1; 9.7; 7.3; 16.4; 12.1 | — |
| SECONDARY Chemotherapy-free Interval (CT-FI) |
17.9 | — |
| SECONDARY Overall Survival (OS) |
32.7 | — |
| SECONDARY Percentage of Patients With Any Improvement From Baseline in Trial Outcome Index (TOI) Score at Any Point During the Treatment Period |
64.3 | — |
| SECONDARY Percentage of Patients With a 10-Point Deterioration From Baseline in TOI Score at Any Point During the Treatment Period |
42.6 | — |
Eligibility Criteria
Key Inclusion Criteria
- Female patients with histologically diagnosed relapsed HGSOC (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid ovarian cancer
- Documented gBRCA1/2 mutation status
- Patients must have completed at least 2 previous courses of platinum containing therapy
- Patients must have normal organ and bone marrow function measured within 28 days of starting study treatment
- ECOG performance status 0-1 (see Appendix E)
- Patients must have a life expectancy ≥16 weeks
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment OR No evidence of disease following a complete response to chemotherapy
- An appropriately prepared tumour sample from the cancer, of sufficient quantity and quality (as specified in the Central Laboratory Services Manual) must be available for future central testing of tumour genetic status
Exclusion Criteria
- Patients receiving any systemic hormonal therapy, chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to start of study treatment
- Any previous treatment with PARP inhibitor, including olaparib
- Patients with a germline BRCA mutation that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental / lead to loss of function)
- Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
- Concomitant use of known strong CYP3A inhibitors and strong (or moderate CYP3A inducers
- Persistent toxicities (≥ Grade 2 Common Terminology Criteria for Adverse Event (CTCAE) adverse event) caused by previous cancer therapy, excluding alopecia
- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML
- Patients with symptomatic uncontrolled brain metastases
Data sourced from ClinicalTrials.gov (NCT03402841) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.