Platine, Avastin and OLAparib in 1st Line (NCT02477644) | Clinical Trial Compass
CompletedPhase 3
Platine, Avastin and OLAparib in 1st Line
Austria806 participantsStarted 2015-05-06
Plain-language summary
Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Platinum-taxane based regimen must have consisted of a minimum of 6 treatment cycles and a maximum of 9. However if platinum based therapy must be discontinued early as a result of non hematological toxicity specifically related to the platinum regimen, (i.e. neurotoxicity, hypersensitivity etc.), patient must have received a minimum of 4 cycles of the platinum regimen.
✓. Intravenous, intraperitoneal, or neoadjuvant platinum based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle. Interval debulking is allowed.
✓. Hemoglobin ≥ 10.0 g/dL.
✓. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
✓. Platelet count ≥ 100 x 109/L.
✓. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
✓. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.
✓. Serum creatinine ≤ 1.25 x institutional ULN and creatinine clearance \> 50 mL/min.
Exclusion criteria
✕. stage \< II,
✕. Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade III endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1 or 2 endometrioid adenocarcinoma.
✕. Myocardial infarction or unstable angina within ≤ 6 months of randomization,
✕. New York Heart Association (NYHA) ≥ grade 2congestive heart failure (CHF).
✕. Poorly controlled cardiac arrhythmia despite medication (patient with rate controlled atrial fibrillation are eligible), or any clinically significant abnormal finding on resting ECG,
✕. Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living \[ADL\] requiring repair or revision).