D9319C00001- 1L OC Mono Global RCT
- Conditions
- Ovarian Cancer
- Registration Number
- NCT04884360
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 367
Key Inclusion Criteria:<br><br> 1. Participants must be =18 years at the time of (pre-)screening<br><br> 2. Histological and staging criteria:Female participants who must have histologically<br> newly diagnosed high-grade serous or high-grade endometrioid ovarian cancer,<br> fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV<br> according to the International FIGO 2014.<br><br> 3. Participants are eligible if they fulfil any of the following surgical criteria:<br><br> - Stage III: primary debulking surgery with macroscopic residual disease<br> post-surgery, neoadjuvant chemotherapy, or inoperable.<br><br> - Stage IV: primary debulking surgery regardless of residual disease, neoadjuvant<br> chemotherapy, or inoperable.<br><br> 4. Chemotherapy criteria:<br><br> - Participants must have received platinum-based chemotherapy consisting of a<br> minimum of 6 treatment cycles and a maximum of 9, however, if platinum-based<br> therapy must be discontinued early as a result of toxicities specifically<br> related to the platinum regimen, participants must have received a minimum of 4<br> cycles of the platinum regimen.<br><br> - Participants must have, in the opinion of the investigator, clinical CR or PR<br> as per RECIST 1.1 criteria with no measurable lesion > 2 cm on the<br> post-treatment scan and have no clinical evidence of disease progression or a<br> rising CA-125 level (see inclusion criterion 5), following completion of this<br> chemotherapy course.<br><br> - A participant who received interval debulking surgery must have had = 2<br> postoperative cycles of platinum-based therapy.<br><br> 5. Participants must meet one of the criteria specified below for pre-treatment CA-125<br> measurements as follows:<br><br> - CA-125 in the normal range or<br><br> - CA-125 decrease by = 90% during their front-line therapy that is stable for at<br> least 7 days (ie, no increase > 15% from nadir). During screening, if the first<br> CA-125 value is greater than the upper limit of normal (ULN), a second<br> assessment must be performed at least 7 days after the first. If the second<br> assessment is > 15% more than the first value, the participant is not<br> eligible).<br><br> 6. Participants should not have received bevacizumab with first-line chemotherapy or be<br> planned to receive bevacizumab maintenance therapy.<br><br> 7. Participants must be randomised within a maximum of 12 weeks from the last day of<br> chemotherapy infusion (but no earlier than 3 weeks).<br><br> 8. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks<br> prior to randomisation.<br><br>9, Provision, at pre-screening, of a formalin-fixed, paraffin-embedded (FFPE) tumour<br>sample to assess tBRCA status and for HRD testing centrally. The centrally performed<br>tBRCA test results must be available prior to randomisation and must indicate that the<br>participant has a BRCAwt tumour, defined by the absence of a deleterious or suspected<br>deleterious BRCA mutation by central testing.<br><br>10, Adequate organ and marrow function.<br><br>Key Exclusion Criteria:<br><br> - 1, Participants with stable disease or progressive disease on the post-treatment<br> scan or clinical evidence of progression at the end of the participant's first-line<br> chemotherapy treatment, or any evidence of progressive disease prior to<br> randomization.<br><br> 2, Participant has mucinous or clear cell subtypes of epithelial ovarian cancer,<br> carcinosarcoma, undifferentiated ovarian cancer, non-epithelial ovarian cancer,<br> borderline tumours or low grade epithelial ovarian tumours (applies to fallopian<br> tube and primary peritoneal tumours where applicable).<br><br> 3, Participants with Stage III disease who have had complete cytoreduction (ie, no<br> macroscopic residual disease) at their primary debulking surgery.<br><br> 4, Participants who have undergone ? 2 debulking (cytoreductive) surgeries.<br><br> 5, History of another primary malignancy except for: malignancy treated with<br> curative intent with no known active disease = 5 years before the first dose of<br> study intervention and of low potential risk for recurrence; Adequately treated<br> non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal<br> carcinoma in situ (DCIS), and Stage 1, Grade 1 endometrial carcinoma. Participants<br> with a history of localised triple negative breast cancer, provided they completed<br> their adjuvant chemotherapy more than three years prior to registration, and that<br> the participant remains free of recurrent or metastatic disease.<br><br> 6, Persistent toxicities (CTCAE Grade =2) caused by previous anticancer therapy,<br> excluding alopecia and CTCAE Grade 2 peripheral neuropathy. Participants with<br> irreversible toxicity that is not reasonably expected to be exacerbated by study<br> intervention may be included after consultation with the AstraZeneca study<br> physician.<br><br> 7, Participant is immunocompromised<br><br> 8, Prior exposure to a PARP inhibitor, including olaparib<br><br> 9, Any concurrent anticancer treatment<br><br> 10, Currently pregnant or breast-feeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard 1st line platinum based chemotherapy treatment.;Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt tumour and a CR/PR following standard 1st line platinum-based chemotherapy treatment.
- Secondary Outcome Measures
Name Time Method