Assessment of Efficacy of AZD2281 in Platinum Sensitive Serous Ovarian Cancer
Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
Astra Zeneca
250 participants
Aug 30, 2008
Interventional
Conditions
Summary
The primary purpose of the study is to determine the efficacy of the study drug AZD2281 compared to placebo by looking at progression free survival of the patients. Progression will be determined by tumour assessments and evaluations and patients will have regular imaging scans. The study hypotheses that AZD2281 given after an objective stable maintained response on completion of platinum containing chemotherapy improves progression free survival compared to placebo in platinum sensitive serous advanced ovarian cancer patients who have previously received two or platinum containing regimens.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
AZD2281 or Olaparib is a potent inhibitor of polyadenosine 5’-diphosphoribose polymerase (PARP) that is being developed as an oral treatment for patients with BRCA (Breast Cancer Gene Type) related cancer. The molecular targeting of olaparib to specific subsets of tumours may provide an opportunity for less toxic cancer monotherapy and adjuvant therapy, compared with currently available regimen. In this study, AZD2281 will be given orally 400mg twice daily. Participants will be receiving AZD2281 till their tumour assessment (via imaging scans) show disease progression according to the protocol. They can chose to stop participating in the study and hence stop receiving the drug. Their doctors or the sponsor may also stop them from receiving the study drug if it was discovered that patient is at risk, non-compliant, or for other reasons.
Locations(9)
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ACTRN12609000159257