Overview
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
Status:
Recruiting
Recruiting
Trial end date:
2027-09-15
2027-09-15
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Mario Negri Institute for Pharmacological ResearchCollaborator:
AstraZenecaTreatments:
Bevacizumab
Olaparib
Criteria
Inclusion Criteria:1. Patient who has completed first line platinum-taxane chemotherapy
2. Patient on treatment with bevacizumab (patient must have received at least 1 cycle of
bevacizumab in combination with chemotherapy). Bevacizumab treatment should have been
administered at a dose of 15mg/kg q3 weeks.
3. Patient must be without evidence of disease (NED) or in complete response (CR) or
partial response (PR) from her first line treatment.
4. Patients with histologically confirmed high-grade epithelial ovarian, fallopian tube
or primary peritoneal cancer and HRD-positive tumor according to the Myriad Mychoice
CDx Plus evaluation.
5. Patients must have normal organ and bone marrow function values measured within 28
days before administration of olaparib
6. Normal blood pressure (BP) or adequately treated and controlled hypertension (systolic
BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg
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 olaparib administration and confirmed the day of treatment
start.
Exclusion Criteria:
1. Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade 2)
caused by previous cancer therapy, excluding alopecia
2. Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features
suggestive of MDS/AML.
3. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence
of brain metastases is not required
4. Patients considered a poor medical risk due to a serious, uncontrolled medical
disorder, non-malignant systemic disease or active, uncontrolled infection.
5. Patients unable to swallow orally administered medication and patients with
gastrointestinal disorders likely to interfere with absorption of the study
medication.
6. Immunocompromised patients, e.g., patients who are known to be serologically positive
for human immunodeficiency virus (HIV).
7. Patients with known active hepatitis (i.e. Hepatitis B or C).
8. Any previous treatment with PARP inhibitor, including Olaparib.
9. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative
reasons) within 3 weeks prior to olaparib.
10. Major surgery within 2 weeks of starting olaparib and patients must have recovered
from any effects of any major surgery
11. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy
or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial
treatment period (hormonal replacement therapy is permitted as are steroidal
antiemetics).
12. Concomitant use of known strong CYP3A inhibitors
13. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin,
rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or
moderate CYP3A inducers
14. Previous allogenic bone marrow transplant or double umbilical cord blood
transplantation (dUCBT).
15. Patients with a known hypersensitivity to olaparib or any of the excipients of the
product.
16. Evidence of any other disease, metabolic dysfunction, physical examination finding or
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of olaparib or puts the patient at high risk for
treatment-related complications.
17. Judgment by the investigator that the patient should not participate in the study if
the patient is unlikely to comply with study procedures, restrictions and
requirements.
18. Breast feeding and pregnant women