OSI-906 & Weekly Paclitaxel in Patients with Recurrent Ovarian Cancer

• Research type

  Research Study

• Full title

  A Phase 1/2 Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients with Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)

• IRAS ID

  21923

• Eudract number

  2009-010319-34

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The purpose of this study was to find out the side effects and safety of a new anticancer drug, OSI-906, when given in combination with an approved anticancer drug called paclitaxel, and to determine the most appropriate dose of OSI-906 and whether it should be given for 3 days out of every 7 days, or continually when given together with paclitaxel. OSI-906 is a new experimental drug that is in the early stages of development. It has been given to over 90 people with cancer. Paclitaxel is a chemotherapy agent that has been approved for use in patients with ovarian, breast, lung, and other cancers. The aim of the study was to evaluate how the body handles both drugs, and the effect both drugs together have against cancer. Although paclitaxel is licensed for use in treating cancer, its use with OSI-906 in this study has not been tested in humans before and so is considered experimental.The study was successfully completed in 2011, and 2 dose levels of OSI-906 were identified for use with weekly paclitaxel, either for 3 days out of every 7 days (600mg) or continually (250mg). An international randomised study involving both schedules together with weekly paclitaxel is now underway in advanced ovarian cancer.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/49

• Date of REC Opinion

  24 Sep 2009

• REC opinion

  Further Information Favourable Opinion