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A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer

NCT01833546 ↗

Phase 1 Completed 20 enrolled Merck KGaA, Darmstadt, Germany Threshold Pharmaceuticals · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Japanese Phase 1, open-label, and dose-escalating trial of TH-302 as monotherapy in subjects with solid tumors and in combination with gemcitabine in subjects with pancreatic cancer.

Timeline

Start
2013-04-18
Primary completion
2015-08-31
Completion
2016-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Evofosfamide Other / unclassified 240 mg/m2 Intravenous
Subject Evofosfamide Other / unclassified 340 mg/m2 Intravenous
Subject Evofosfamide Other / unclassified 480 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 —

Indications

malignant pancreatic neoplasm