Avastin EXTENSION

• Research type

  Research Study

• Full title

  A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY OF BEVACIZUMAB IN PATIENTS WITH SOLID TUMOURS ON STUDY TREATMENT WITH BEVACIZUMAB, AT THE END OF A F. HOFFMANN-LA ROCHE AND/OR GENENTECH SPONSORED STUDY (MO25757)

• IRAS ID

  102181

• Contact name

  Timothy Eisen

• Eudract number

  2011-002009-31

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Clinical trials need to have a defined end. This end can be a specific event or be a pre-specified time after the first visit of the last patient included in the trial. At completion or closure of any trial some patients might still be on study treatment and benefit from its continuation. Avastin has been tested in a variety of cancers alone or combined with chemotherapy. In the European Union, Avastin is approved for use in several cancers. Avastin is usually given until progression of the underlying cancer unless patients withdraw consent or experience toxicities that lead to earlier discontinuation. The time to progression is very variable from patient to patient. Roche/Genentech has committed to provide treatment for patients treated in clinical trials with Avastin after the completion of clinical trials, if their cancer has not progressed. This ensures that all patients enrolled in the same trial receive similar treatment from start of study treatment until their disease progresses. The objective of this multicentre, open-label, single-arm phase IIIb/IV study is to provide continued Avastin therapy alone or combined with other anti-cancer drugs to patients with cancer, who were previously enrolled in a Roche/ Genentech sponsored Avastin study (the Parent-trial or P-trial) and derived benefit from the treatment administered in the P-trial. Another study objective is to collect safety data with regard to the long-term administration of Avastin. Eligible patients are those who are treated with Avastin at the end of a P-trial who continue to have benefit with Avastin treatment and are eligible for continuation of bevacizumab treatment. The study will enrol patients over 5 years. The number of patients is not fixed, all patients on qualifying P-trials may be enrolled. This study will describe the safety and outcomes of treatment with Avastin in a broad population of cancer patients.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  12/SC/0241

• Date of REC Opinion

  5 Jul 2012

• REC opinion

  Further Information Favourable Opinion