Threshold Pharmaceuticals, Inc. has initiated patient enrolment for a phase 1/2 clinical trial evaluating the dosing, safety and activity of Glufosfamide in combination with gemcitabine for treating advanced solid malignancies or as a first line treatment for pancreatic cancer.
Phase 1 of the Glufosfamide/gemcitabine study will evaluate various doses of Glufosfamide in combination with the standard dose of gemcitabine in patients with any kind of advanced solid malignancy for which gemcitabine is currently a treatment option. The phase 1 portion of this study may enrol up to 15 patients. The maximum tolerable dose combination determined in phase 1 of the study will be used in the phase 2 portion to treat patients with pancreatic cancer. Approximately 47 men and women with advanced pancreatic cancer will be enrolled in the phase 2 clinical trial at various sites in the US and Latin America, the company release said.
Earlier this year, Threshold announced the initiation of a pivotal phase 3 clinical trial to evaluate Glufosfamide in patients with metastatic pancreatic cancer refractory to first-line treatment. The data from that trial will be evaluated under a Special Protocol Assessment (SPA) granted by the FDA.
"With so few effective first-line therapies available for pancreatic cancer patients, our hope is that the Glufosfamide/gemcitabine combination will emerge as the powerful new therapy these patients so desperately need," said George Tidmarsh, president of Threshold Pharmaceuticals.
Results from previous phase 1 and 2 clinical trials have demonstrated that Glufosfamide shows activity against pancreatic cancer. In an initial phase 1 trial of Glufosfamide in patients with a variety of solid tumours, published in the Journal of Clinical Oncology (Oct. 2000), the only pancreatic cancer patient enrolled in the trial achieved a complete remission of disease and remained in remission more than five years after receiving Glufosfamide treatment alone, the release added.