WASHINGTON (dpa-AFX) - OncoGenex Pharmaceuticals Inc. (OGXI) announced the initiation of ENSPIRIT, a Phase 3 trial evaluating custirsen for the treatment of advanced or metastatic non-small cell lung cancer or NSCLC in patients who have progressed after initial chemotherapy treatment has failed.
The company said that the trial will investigate if combining custirsen with docetaxel, a standard second-line NSCLC chemotherapy, has the potential to improve survival outcomes compared to docetaxel alone in these patients. Two formal interim analyses are planned for stopping the trial early based on inadequate evidence of clinical benefit or futility. No interim analyses for claiming efficacy are planned.
Custirsen received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treatment of patients with castrate-resistant prostate cancer (CRPC) receiving first-line docetaxel chemotherapy. The Phase 3 SYNERGY study, evaluating a survival benefit in the first-line CRPC setting, continues to accrue patients and is expected to complete enrollment later this year.
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