A Phase 2, ABT-888 and Temozolomide Study in Recurrent Ovarian Cancer

• Research type

  Research Study

• Full title

  A Phase 2 Randomized Clinical Trial of ABT-888 in Combination with Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Subjects with Recurrent High Grade Serous Ovarian Cancer

• IRAS ID

  40768

• Contact name

  Shibani Nicum

• Sponsor organisation

  Abbott Laboratories

• Eudract number

  2009-015082-31

• ISRCTN Number

  n/a

• Research summary

  This study will compare a new treatment, ABT-888 with temozolomide, and an approved treatment, pegylated liposomal doxorubicin alone, in patients with recurrent high grade serous ovarian cancer to see how well each treatment works and how safely. In the UK, more than 6,600 cases of ovarian cancer are diagnosed each year and about 4,400 women die from the disease. Despite effective surgery and good response rates initially to current treatments, recurrence rates are high. Effective treatments in this recurrent population are much needed. ABT-888 is a new drug called a PARP inhibitor. This means it works by stopping the body repair cancer cells that are damaged by cancer treating drugs. By combining ABT-888 and temozolomide, a drug currently used in solid tumours, the two drugs may work better together to slow down tumour growth or to help reduce their size. 150 patients with confirmed recurrent high grade serous ovarian cancer, primary peritoneal cancer or fallopian tube cancer can enter this study if they have already received a number of treatments for their disease and meet a number of safety criteria. The study is funded by Abbott and will run in about 40 sites in North America, South America, Europe, Israel, Australia and New Zealand and includes 3 sites in the UK. If eligible, patients will visit the hospital weekly for the first two cycles of treatment and then monthly whilst they are clinically benefiting and managing any side effects. Patients will undergo blood tests, scans, physical examinations and complete questionnaires to see how the treatment is working. The study will end when the last patient randomised has been followed for disease progression for up to 6 months or if all 150 patients complete the study before this.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/11

• Date of REC Opinion

  14 Apr 2010

• REC opinion

  Further Information Favourable Opinion