First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients (NCT06121401) | Clinical Trial Compass
Active — Not RecruitingPhase 4
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
Italy190 participantsStarted 2023-09-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia
What they're measuring
1
Proportion of patients treated with olaparib
Timeframe: 42 months
2
Efficacy of olaparib
Timeframe: 42 months
Trial details
NCT IDNCT06121401
SponsorMario Negri Institute for Pharmacological Research
. 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.