Status:
ACTIVE_NOT_RECRUITING
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
AstraZeneca
Conditions:
Carcinoma, Ovarian Epithelial
Eligibility:
FEMALE
18-75 years
Phase:
PHASE4
Brief 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...
Detailed Description
This phase IV study will include two translational research projects: 1. The analyses of the circulating-tumor DNA (ctDNA) derived from plasma samples collected at different time points (liquid biops...
Eligibility Criteria
Inclusion
- Patient who has completed first line platinum-taxane chemotherapy
- 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.
- Patient must be without evidence of disease (NED) or in complete response (CR) or partial response (PR) from her first line treatment.
- 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.
- Patients must have normal organ and bone marrow function values measured within 28 days before administration of olaparib
- 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
- Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Patients with known active hepatitis (i.e. Hepatitis B or C).
- Any previous treatment with PARP inhibitor, including Olaparib.
- Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to olaparib.
- Major surgery within 2 weeks of starting olaparib and patients must have recovered from any effects of any major surgery
- 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).
- Concomitant use of known strong CYP3A inhibitors
- Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- 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.
- 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.
- Breast feeding and pregnant women
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2027
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06121401
Start Date
September 15 2023
End Date
September 15 2027
Last Update
September 17 2025
Active Locations (2)
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1
Azienda Socio Sanitaria Territoriale (ASST) Lariana
San Fermo della Battaglia, Como, Italy, 22042
2
Istituto Oncologico Veneto IRCCS
Padua, Italy, Italy, 35128