Date: 2014-07-01
Type of information: Initiation of patient enrollment
phase: 2
Announcement: initiation of patient enrollment
Company: OncoGenex Pharmaceuticals (USA - WA)
Product: apatorsen
Action
mechanism: Apatorsen is a once-weekly intravenous experimental antisense oligonucleotide that is designed to inhibit production of Hsp27 to disable cancer cells\' defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes.
Disease: previously untreated patients with advanced squamous cell lung cancer
Therapeutic area: Cancer - Oncology
Country: UK
Trial
details: Cedar is an investigator-sponsored trial being conducted and funded primarily by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and will involve approximately 20 centers in the United Kingdom. A Phase II, randomised, open-label study of Gemcitabine/Carboplatin first-line chemotherapy in combination with or without the antisense oligonucleotide Apatorsen (OGX427) in advanced squamous cell lung cancers
Latest
news: * On July 1, 2014, OncoGenex Pharmaceutical announced initiation of the Cedar™ clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer. Apatorsen is a once-weekly intravenous (IV) experimental drug that is designed to inhibit production of heat shock protein 27 (Hsp27) to disable cancer cells\' defenses and overcome treatment resistance. Approximately 140 patients with previously untreated stage IV or recurrent squamous cell lung cancers or stage IIIB squamous cell cancers that are not amenable to radiochemotherapy will be randomized to receive either apatorsen plus gemcitabine and carboplatin therapy, or gemcitabine and carboplatin therapy alone. The primary objective is progression-free survival (PFS), with secondary objectives to evaluate tumor response rates, overall survival, safety, tolerability, and health-related quality of life. Additional analyses will be conducted to determine the effect of therapy on Hsp27 levels and to explore potential biomarkers that may help predict response to treatment.
