THRESHOLD BEGINS TRIAL IN PLATINUM-RESISTANT OVARIAN CANCER

Threshold Pharmaceuticals has initiated patient enrollment in a Phase II clinical trial evaluating the dosing, safety and activity of glufosfamide in patients with platinum-resistant ovarian cancer.

Platinum-based therapy is the most widely used chemotherapy to treat ovarian cancer, but some women develop resistance to it, according to Threshold. The current standards of care in treating platinum-resistant ovarian cancer are a variety of single-agent and combination regimens including topotecan and anthracyclines such as doxorubicin, gemcitabine, cyclophosphamide, vinorelbine, hexamethylmelamine, ifosfamide and etoposide.

The trial will evaluate two dosing schedules of glufosfamide, a once-weekly schedule and the schedule currently used in pancreatic cancer trials, which is once every three weeks. The trial will explore the administration of slightly higher aggregate doses using the weekly schedule as compared with once-every-three-week dosing. All patients may receive up to six 21-day cycles. 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 regimens will be enrolled in the Phase II, open-label 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 tumor assessments and overall survival.