Olaparib with Carboplatin and Paclitaxel in Relapsed Ovarian Cancer

• Research type

  Research Study

• Full title

  A Phase II, Open Label, Randomised, Comparative, Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination with Paclitaxel and Carboplatin and Versus Paclitaxel and Carboplatin Alone in Patients with Platinum Sensitive Advanced Serous Ovarian Cancer

• IRAS ID

  34022

• Contact name

  Christopher J Poole

• Sponsor organisation

  AstraZeneca UK

• Eudract number

  2009-015970-36

• ISRCTN Number

  TBC

• Research summary

  This study will examine whether giving olaparib in combination with standard chemotherapy is better than chemotherapy alone. Patients in the study will have advanced ovarian cancer that has recurred despite one or more courses of platinum based chemotherapy.Once patients have undergone the screening assessments and confirmed as suitable for the study, patients will be split into two groups at random; half will receive the olaparib capsules in combination with a reduced dose of chemotherapy, whereas the other half will be given the chemotherapy that they would normally expect to receive without olaparib. Once their treatment is allocated, patients will attend the hospital weekly for the first 6 weeks, and then every 3 weeks until completion of chemotherapy. After they have completed a course of 6 cycles of chemotherapy, patients allocated olaparib with their chemotherapy will continue to receive olaparib maintenance monotherapy until their cancer progresses for the worse known as relapse. Patients on the chemotherapy only arm will receive no further study treatment until they relapse or progress. Patients on both arms of the trial will continue to attend every 12 weeks for CT scans to monitor the response of their cancer to treatment. Once their cancer has either relapsed or progressed they will not need any further scans. Their further treatment will then be at the discretion of the responsible clinical team, based on local and national guidelines. In respect of the study, they will contacted every 12 weeks by phone to check survival status.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/110

• Date of REC Opinion

  20 Jan 2010

• REC opinion

  Further Information Favourable Opinion