A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer

Phase 1 Completed 20 enrolled RenovoRx

Non-randomizedSequentialOpen-labelOther

Summary

A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.

Timeline

Start: 2015-03
Primary completion: 2016-09
Completion: 2016-09

Publications

Hatoum H, Rosemurgy A 2nd, Bastidas JA, Zervos E, Muscarella P 2nd, Edil BH, Cynamon J, Johnson DT, Thomas C, Swinson BM, Nordgren A, Vitulli P, Nutting C, Gipson M, Tsobanoudis A, Agah R. Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2. Oncologist. 2024 Aug 5;29(8):690-698. doi: 10.1093/oncolo/oyae178.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	250 mg/m2	Other
Subject	Gemcitabine	Small molecule	500 mg/m2	Other
Subject	Gemcitabine	Small molecule	750 mg/m2	Other
Subject	Gemcitabine	Small molecule	1000 mg/m2	Other

A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer

Summary

Timeline

Publications

Drugs

Indications