Phase II AZD2281 in platinum sensitive serous ovarian cancer

• Research type

  Research Study

• Full title

  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

• IRAS ID

  4848

• Contact name

  Jonathan Ledermann

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2008-003439-18

• ISRCTN Number

  Not submitted

• Research summary

  Ovarian cancer commonly presents at late stage and therefore prognosis is not good. It is the 4th most common cause of cancer death in women. Standard care involves surgery and chemotherapy. Despite achieving clinical complete remission in approximately 75% of patients following platinum-based chemotherapy, most patients relapse. In many cases women will respond again to chemotherapy but in this situation the time to further progression is usually less that a year and survival of patients from progression is about 2 years on average. While classical chemotherapy drugs attack all cells that grow rapidly, a lot of drug development today is based on molecular targets; trying to find specific molecules that may render cancer cells more vulnerable to being destroyed by a therapeutic agent.AZD2281 (olaparib) belongs to a new class of drugs called PARP inhibitors. It works by interrupting DNA repair in the cancerous cells leading to their destruction.AstraZeneca is sponsoring a study to develop AZD2281 as a new anti cancer agent. So far, more than 340 patients suffering from ovarian, breast, pancreatic, and a variety of other advanced solid tumours have been exposed to AZD2281. AZD2281 has been generally well tolerated and appears less toxic compared to other cancer therapies.Adult patients with ovarian cancer who have responded to two or more previous platinum containing chemotherapy regimens will be randomly assigned to one of two treatment groups;1. AZD2281 400mg twice daily2. Placebo (looks exactly the same as AZD2281 but does not contain active drug) twice dailyThe study is randomised, meaning that patients will be randomly allocated to a treatment group. It is also double blind therefore neither the study doctor nor the patient will be aware of what treatment (active or placebo) is being administered. The time to disease progression in the two groups will be compared.This is a multicentre study which will take place in approximately 60 centres worldwide. It is anticipated that approximately 250 patients will be recruited worldwide, 30 of those in the UK.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/100

• Date of REC Opinion

  7 Jan 2009

• REC opinion

  Further Information Favourable Opinion