CTRI/2021/08/035759
Recruiting
Phase 3
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Olaparib Maintenance Monotherapy in Participants with BRCA Wild Type Advanced (FIGO Stage III-IV) High Grade Serous or Endometrioid Ovarian Cancer Following Response to Standard First-line Platinum-based ChemotherapyMONO-OLA1 - NA
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
- Sponsor
- AstraZeneca AB
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participants must be \=18 years at the time of (pre\-)screening.
- •Type of Participant and Disease Characteristics
- •2\. Histological and staging criteria:
- •Female participants who must have histologically newly diagnosed high\-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) criteria
- •3\. Participants are eligible if they fulfil any of the following surgical criteria:
- •I.Stage III: primary debulking surgery with macroscopic residual disease post\-surgery,
- •II.neoadjuvant chemotherapy, or inoperable.
- •III.Stage IV: primary debulking surgery regardless of residual disease, neoadjuvant
- •IV.chemotherapy, or inoperable.
- •Note: the receipt of intraperitoneal chemotherapy is permitted
Exclusion Criteria
- •Medical Conditions
- •1\. Participants with stable disease or progressive disease on the post\-treatment scan or clinical evidence of progression at the end of the participant s first\-line chemotherapy treatment, or any evidence of progressive disease prior to randomisation.
- •2\. Participant has mucinous or clear cell subtypes of epithelial ovarian cancer,
- •carcinosarcoma, undifferentiated ovarian cancer, non\-epithelial ovarian cancer, borderline tumours or low grade epithelial ovarian tumours (applies to fallopian tube and primary peritoneal tumours where applicable).
- •3 Participants with Stage III disease who have had complete cytoreduction (ie, no macroscopic residual disease) at their primary debulking surgery.
- •4 Participants who have undergone ? 2 debulking (cytoreductive) surgeries.
- •5\. History of another primary malignancy except for malignancy treated with curative intent with no known active disease \= 5 years before the first dose of study intervention including 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 Participants with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the participant remains free of recurrent or metastatic disease.
- •6\. As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases or active, uncontrolled infection, including but not limited to, uncontrolled ventricular arrhythmia, uncontrolled hypertension, recent \[within 3 months] myocardial infarction, uncontrolled major seizure disorder, renal transplant, active bleeding diseases, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography \[HRCT] scan) which, in the investigator s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
- •7\. Participants unable to swallow orally administered medication and participants with gastrointestinal disorders that would preclude adequate absorption, distribution, metabolism, or excretion of olaparib.
- •8\. Persistent toxicities (CTCAE Grade \=2\) caused by previous anticancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss) after consultation with the AstraZeneca study physician.
Outcomes
Primary Outcomes
Not specified
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