Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

NCT02047500 ↗

Phase 1 Terminated 19 enrolled ImmunoGenesis Threshold Pharmaceuticals · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.

Timeline

Start: 2014-01
Primary completion: 2015-09
Completion: 2016-05

Publications

Sun JD, Liu Q, Ahluwalia D, Li W, Meng F, Wang Y, Bhupathi D, Ruprell AS, Hart CP. Efficacy and safety of the hypoxia-activated prodrug TH-302 in combination with gemcitabine and nab-paclitaxel in human tumor xenograft models of pancreatic cancer. Cancer Biol Ther. 2015;16(3):438-49. doi: 10.1080/15384047.2014.1003005.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evofosfamide	Other / unclassified	170 mg/m2	Intravenous
Subject	Evofosfamide	Other / unclassified	340 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	125 mg/m2	Intravenous

Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

Summary

Timeline

Publications

Drugs

Indications