Threshold Pharma Begins Enrollment in Soft-Tissue Sarcoma Study

Threshold Pharmaceuticals has begun patient enrollment in a Phase II clinical trial evaluating the efficacy and safety of glufosfamide in patients with previously treated, advanced, soft-tissue sarcoma. Soft tissue sarcoma includes cancers of cartilage, fat, muscle, blood vessels or other connective or supportive tissue.

Twenty-two patients with previously treated, advanced, soft-tissue sarcoma will be enrolled in the Phase II, open-label clinical trial at various sites in the U.S. All patients are to 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 include duration of response, progression free survival, overall survival and various safety parameters. Tumor response will be evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors.

One exploratory objective of the trial is to evaluate the biological effects of glufosfamide on metabolic profile as determined by fluorodeoxyglucose-positron emission tomography. The role of this procedure is to detect metabolically active malignant lesions and to monitor their metabolic responses to glufosfamide therapy. An additional exploratory objective of the trial is to correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins.