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Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Other Non-Commercial Sponsor
Olaparib is the study intervention in this trial. Olaparib (LynparzaTM) is a poly(ADP-ribose) polymerase (PARP) inhibitor. The inactive ingredients are copovidone, colloidal silicon dioxide, mannitol, sodium stearyl fumarate, hydroxypropyl methylcellulose (hypromellose), macrogol 400 (polyethylene glycol 400), titanium dioxide, iron oxide yellow and iron oxide black.
It is provided as tablets each containing 100mg or 150mg olaparib for oral administration. administered as 300 mg orally twice daily until disease progression or unacceptable toxicity. Each bottle contains 32 tablets. Patients will be asked to return unused drug and empty drug containers at each return visit for adherence.
Olaparib should be commenced within 7 days after registration and will be continued until disease progression or unacceptable toxicity.