Testing TH-302, in Combination With Preoperative Chemoradiotherapy, in Esophageal Cancer.

Phase 1 Withdrawn Maastricht Radiation Oncology Threshold Pharmaceuticals · collab Zuyderland Medical Centre · collab

NaSingle-groupOpen-labelTreatment

Summary

Open-label, single-center phase 1 study of an investigational agent TH-302 and standard chemoradiotherapy with a 3+3 dose escalation design through 3 dose levels.

Timeline

Start: 2015-12
Primary completion: 2016-04
Completion: 2016-04

Outcome

Outcome not reported

Stopped: “2 Phase 3 trials didn't meet their primary endpoint, so further development and testing of TH-302 is uncertain”

Publications

Larue RT, Van De Voorde L, Berbee M, van Elmpt WJ, Dubois LJ, Panth KM, Peeters SG, Claessens A, Schreurs WM, Nap M, Warmerdam FA, Erdkamp FL, Sosef MN, Lambin P. A phase 1 'window-of-opportunity' trial testing evofosfamide (TH-302), a tumour-selective hypoxia-activated cytotoxic prodrug, with preoperative chemoradiotherapy in oesophageal adenocarcinoma patients. BMC Cancer. 2016 Aug 17;16:644. doi: 10.1186/s12885-016-2709-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evofosfamide	Other / unclassified	120 mg/m2	—
Subject	Evofosfamide	Other / unclassified	340 mg/m2	—
Background	Carboplatin	Small molecule	2 mg/ml	—
Background	Paclitaxel	Small molecule	50 mg/m2	—