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Threshold completes enrollment in pivotal phase 3 and phase 2 trials of glufosfamide in pancreatic cancer
By Lisa Kerner
Charlotte, N.C., Aug. 8 - Threshold Pharmaceuticals, Inc. said it has completed enrollment in a pivotal phase 3 and a phase 2 clinical trial evaluating glufosfamide in the treatment of pancreatic cancer. Top-line results from the clinical trials are expected by the end of the year, officials said.
The phase 3 trial will evaluate glufosfamide as a potential second-line treatment in 300 previously treated patients with locally advanced and/or metastatic pancreatic cancer receiving receive best supportive care (BSC) or glufosfamide (4500mg/m2) once every 3 weeks plus BSC.
Primary endpoint of this trial is overall survival as measured by time from randomization to death. Final analysis will be conducted following the 258th death, according to a company news release.
Threshold said the phase 3 trial, being conducted under a Special Protocol Assessment, will evaluate up to 28 previously untreated patients with locally advanced and/or metastatic pancreatic cancer who receive the standard dose of gemcitabine (1000mg/m2) weekly for 3 of every 4 weeks plus glufosfamide (4500mg/m2) administered once every 4 weeks.
This trial will investigate the efficacy of glufosfamide in combination with gemcitabine as determined by response rate, duration of response, progression-free survival, overall survival, six- and twelve-month survival and change in serum tumor marker levels.
Threshold said previous trials have demonstrated that glufosfamide kills cancer cells and can shrink pancreatic cancers.
According to the American Cancer Society, roughly 33,730 patients will be diagnosed with pancreatic cancer in the United States in 2006, and approximately 32,300 patients will die from the disease.
Threshold is a biotechnology company develops small molecule therapeutics for the potential treatment of cancer.
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