THRESHOLD BEGINS TRIAL OF DRUG FOR SMALL-CELL LUNG CANCER

Threshold Pharmaceuticals has initiated patient enrollment in a Phase II clinical trial evaluating the efficacy and safety of glufosfamide in patients with recurrent, sensitive, small-cell lung cancer.

The current standards of care in treating recurrent, sensitive, small-cell lung cancer are a variety of single-agent and combination regimens including topotecan, cyclophosphamide, doxorubicin, vincristine, irinotecan, ifosfamide and cisplatin, according to the company.

The company plans to enroll approximately 50 patients with extensive recurrent, sensitive, small-cell lung cancer, who have progressed at least 60 days after completing chemotherapy, into the open-label trial at various sites in the U.S., Ukraine and Russia. All patients will receive 5,000 mg/m2 of glufosfamide every three weeks for up to six cycles.

The primary efficacy endpoint of the trial is objective response rate. The secondary endpoints of the trial will evaluate duration of response, progression-free survival, overall survival, time to response and various safety and pharmacokinetic parameters. The study will also evaluate the effects of glufosfamide on lung cancer symptoms utilizing the Lung Cancer Symptom Scale.

The clinical trial will use a two-stage design to ensure there is an adequate response rate to justify complete enrollment. The first stage will enroll 21 patients, and at the end of this stage the trial will be stopped if fewer than three patients have a response. If three or more responses are observed, an additional 29 patients will be enrolled. Tumor response will be evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors.