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news.Threshold Pharmaceuticals has started a multi-center, randomised, controlled, crossover Phase 2 clinical trial evaluating TH-302 in combination with gemcitabine in patients with first line pancreatic cancer.
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TH-302 is a proprietary tumor selective Hypoxia-Activated Prodrug (HAP) that specifically targets tumor hypoxia.
Threshold Pharma is expected to enroll approximately 165 patients with previously untreated, locally advanced, unresectable or metastatic pancreatic adenocarcinoma in the clinical trial at various sites in the US and Canada.
Threshold Pharmaceuticals said that the primary endpoint of the trial is progression free survival while the secondary endpoints are overall response rate, overall survival, event-free survival, CA 19-9 response rate as well as various safety parameters.
In the trial, tumor response will be evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST).
Mitesh Borad, associate director at the Mayo Clinic in Arizona and clinical investigator for this and previous trials of TH-302, said: “TH-302 has been investigated in Phase 1/2 clinical trials in over 300 patients, including 50 patients with pancreatic cancer.
“This new randomised clinical trial is designed to confirm the results that were observed and recently reported in patients with pancreatic cancer.
“Given the promising results observed to date in the Phase1/2 trials with TH-302, I am looking forward to continuing our participation as TH-302 enters this next phase of clinical development.”