Epithelian ovarian cancer MedDRA version: 19.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Patients must be =18 years of age 3. Female patients with histologically diagnosed relapsed non-mucinous EOC (including primary peritoneal and/or fallopian tube cancer) 4. Documented BRCA1/2 status 5. Patients must have received one prior PARPi therapy or blinded treatment in a trial with a PARPi as the experimental arm 6. Patients must have normal organ and bone marrow function measured within 28 days of randomisation, as defined below. In the event of minor deviations from these values which would lead to screen failure, repeat testing within the 28-day screening period is allowed before the patient is declared a screen failure. 7. ECOG performance status 0-1 8. Patients must have a life expectancy =16 weeks 9. 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 10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations 11. 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 measurable disease following a complete response to chemotherapy 12. A formalin fixed, paraffin embedded tumour sample from the cancer of sufficient quantity and quality must be available for future central testing of tumour genetic status. If a recent biopsied sample is provided, the biopsied tumour should not be assessed as target lesions as part of the RECIST assessments if there are other lesions available, and the biopsy should be taken after the baseline scan has been performed. Archival tissue samples may be from the primary tumour or metastatic tumour deposits. Archival bone metastases are not acceptable. Provision of blocks is preferred. Alternatively pre-cut 5µm thick, unstained sections from the FFPE block may be provided. Any exceptions to these conditions should be discussed with the Sponsor before randomisation of the patient. 13. For inclusion in the optional biomarker research, patients must fulfil the following criteria: Provision of informed consent for biomarker research. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 302 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: 1. Involvement in the planning and/or conduct of the study 2. Previous randomisation in the present study 3. Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation. 4. Other malignancy within the last 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, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for =5 years. Patients with history of primary breast cancer may be eligible provided they completed their definitive anticancer treatment more than 3 years ago and they remain breast cancer disease free prior to start of study treatment 5. Resting electrocardiogram (ECG) with corrected QT interval (QTc) >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome 6. Patients receiving any systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment 7. Concomitant use of known strong cytochrome P450 subfamily 3A (CYP3A) inhibitors or moderate CYP3A inhibitors. The required washout period prior to starting study treatment is 2 weeks 8. Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents 9. Persistent toxicities caused by previous cancer therapy, excluding alopecia 10. Patients with current or previous myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML 11. Patients with symptomatic uncontrolled brain metastases. 12. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery 13. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. 14. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication 15. Breast feeding women 16. Immunocompromised patients 17. Patients with a known hypersensitivity to Olaparib or any of the excipients of the product 18. Patients with known active hepatitis due to risk of transmitting the infection through blood or other body fluids 19. Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation 20. Whole blood transfusions in the last 120 days prior to randomisation to the study (packed red blood cells and platelet transfusions are acceptable).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of Olaparib maintenance retreatment compared to matching placebo by assessment of progression-free survival (PFS);Secondary Objective: To determine the efficacy of Olaparib maintenance retreatment compared to matching placebo by assessment of overall survival (OS) To determine the efficacy of Olaparib maintenance retreatment compared to matching placebo by assessment of time to progression by Gynecologic Cancer Intergroup (GCIG) criteria To determine the efficacy of Olaparib maintenance retreatment compared to matching placebo by assessment of the use of subsequent therapies and study treatment discontinuation To determine the HRQoL of Olaparib maintenance retreatment compared to matching placebo as measured by the Functional Assessment of Cancer Therapy – Ovarian (FACT-O) Trial Outcome Index (TOI) To evaluate the safety and tolerability of Olaparib maintenance retreatment ;Primary end point(s): Progression free survival.;Timepoint(s) of evaluation of this end point: Throughout the whole study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall surivival Time to first subsequent therapy or death. Time to second subsequent therapy or death. Time to treatment discontinuation or death. Time to earliest progression by RECIST, CA-125 or death. Change in FACT-O TOI. Treatment-emergent adverse events.;Timepoint(s) of evaluation of this end point: Throughout the whole study. | — |
Countries
Belgium, Denmark, France, Germany, Israel, Italy, Norway, Poland, Spain, United Kingdom
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed