Phase 3 REOLYSIN study in metastatic or recurrent Head and Neck Cancer

• Research type

  Research Study

• Full title

  Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination with Paclitaxel and Carboplatin versus the Chemotherapy Alone in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck who have Progressed on or after Prior Platinum-Based Chemotherapy

• IRAS ID

  42513

• Contact name

  Kevin Harrington

• Sponsor organisation

  Oncolytics Biotech Inc.

• Eudract number

  2009-016940-38

• ISRCTN Number

  n/a

• Research summary

  This is a double-blind phase 3 randomised, multicentre, 2-stage study in patients with metastatic or recurrent histologically confirmed squamous cell carcinoma. REOLYSIN© is a reovirus which has the ability to replicate in and destroy transformed cells possessing an activated Ras signalling pathway- often found in malignant cells. It also may have a synergistic effect on other standard chemotherapies without changing the safety profile All patients must meet the inclusion/exclusion criteria and will receive paclitaxol followed by carboplatin IV infusions every 3 weeks for up to 8 cycles. One group will also receive IV blinded placebo and the other will receive IV blinded REOLYSIN© on days 1-5 of each cycle. The treatment will be continued until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. 80 evaluable patients will be enrolled in the first phase and between 100 and 400 in the second stage. The sample in Stage 2 will be determined adaptively.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/17

• Date of REC Opinion

  1 Apr 2010

• REC opinion

  Further Information Favourable Opinion