Threshold Cancer Drug Fails Study Endpoint
Posted on: Friday, 12 October 2007, 12:00 CDT
Threshold Pharmaceuticals has stopped enrolling patients in a Phase II clinical trial after its experimental drug glufosfamide failed to demonstrate efficacy endpoints in treating small cell lung cancer.
The clinical trial utilized a two stage design to ensure there would be an adequate response rate to justify complete enrollment. Tumor response was evaluated at baseline and every 6 weeks using the response evaluation criteria in solid tumors (RECIST). The first stage enrolled 21 patients as planned, but only one confirmed partial response was observed. If 3 or more responses were observed, an additional 29 patients would have been enrolled. Patients currently enrolled in the clinical trial will be given the option to continue in the trial.
Barry Selick, CEO, said: "We are disappointed in the study results. While we recognize that response is not a perfect surrogate for survival, the low response rate indicates that glufosfamide is not sufficiently effective as a single agent for patients with small cell lung cancer. We had hoped to develop a better treatment option for patients with this disease, for whom the quality of life and treatment outcomes need improvement. We want to thank the investigators, patients and their families for their participation in the study."
Source: Datamonitor
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