Oncolytics Initiates US Phase II Lung Cancer Trial
Posted on: Tuesday, 2 September 2008, 09:00 CDT
Oncolytics Biotech has announced that following the FDA review, the company is initiating a US Phase II clinical trial using intravenous administration of Reolysin in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer with K-RAS or EGFR-activated tumors.
This trial is a single arm, two-stage, open-label, Phase II study of Reolysin given intravenously with paclitaxel and carboplatin every three weeks. Patients will receive four to six cycles of paclitaxel and carboplatin in conjunction with Reolysin, at which time Reolysin may be continued as a monotherapy. It is anticipated that up to 36 patients will be treated in this trial.
Eligible patients include those with metastatic or recurrent non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumors, who have not received chemotherapy treatment for their metastatic or recurrent disease. Patients must have demonstrated mutations in K-RAS or EGFR, or EGFR gene amplification in their tumors in order to qualify for the trial.
The primary objectives of the Phase II trial are to determine the objective response rate of Reolysin in combination with paclitaxel and carboplatin in patients with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumors, and to measure progression-free survival at six months.
The secondary objectives are to determine the median survival and duration of progression-free survival in patients, and to evaluate the safety and tolerability of Reolysin in combination with paclitaxel and carboplatin in this patient population.
Brad Thompson, president and CEO of Oncolytics, said: "This trial gives Oncolytics the opportunity to treat NSCLC patients in a first-line clinical setting. Assuming we achieve an acceptable response rate, the combination of Reolysin with paclitaxel and carboplatin for NSCLC would be a strong candidate for registration studies."
Source: Datamonitor
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