18 Nov 2010 08:25am EST
Threshold Pharmaceuticals, Inc. announced clinical trial results related to Threshold's clinical stage hypoxia-activated prodrug, TH-302. Today's presentation focused on two clinical trials, the 402 trial and the 403 trial. The 402 trial is a Phase 1/2, three arm, multicenter, dose escalation and dose expansion trial to determine the safety, efficacy and pharmacokinetics of TH-302 in combination with gemcitabine (Gem) or docetaxel (Doc) or pemetrexed (Pem) in patients with various advanced solid tumors including, but not limited to, advanced or metastatic pancreatic cancer, castrate-resistant prostate cancer (CRPC) and relapsed or refractory non-small cell lung cancer (NSCLC). The 403 trial is investigating TH-302 in combination with doxorubicin (Dox) in patients with advanced soft tissue sarcoma. Additionally, in the gemcitabine treatment arm, median progression free survival (PFS) was 6.4 months (95% CI: 4.7 to 7.7 months). Among the patients with relapsed or refractory NSCLC, median PFS was 4.2 months (95% CI: 2.8 months to not reached). Among the 15 patients with CRPC, 11 (73%) had a PSA decline of at least 50%. Among the patients with soft tissue sarcoma, median PFS was 6.4 months (95% CI: 5.6 to 6.9 months). Overall, hematologic toxicity was acceptable and skin and mucosal toxicities were well managed at current dose levels.
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