Threshold Pharmaceuticals has initiated enrollment for a phase II trial evaluating the dosing, safety and activity of glufosfamide in patients with platinum-resistant ovarian cancer.
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Platinum based therapy is the most widely used chemotherapy to treat ovarian cancer, but some women develop resistance to it.
“There are very few drugs that will effectively treat platinum-resistant disease,” said David Alberts, director of the Arizona Cancer Center at the University of Arizona.
The clinical trial will evaluate two dosing schedules of glufosfamide, a once weekly schedule and the schedule currently utilized in pancreatic cancer trials, which is every three weeks.
Overall, 45 women with ovarian cancer who have previously relapsed after up to four prior chemotherapy regimens, including one or two prior platinum-containing regimens, and who have demonstrated resistance to their last platinum-containing regimen will be enrolled in the phase II trial.
In addition to safety, the trial is investigating the efficacy of glufosfamide as determined by response rate, duration of response and progression-free survival based on changes in the serum tumor marker level CA-125 and based on tumor assessments and overall survival.