Phase I Trial of ZIO-101 in Patients With Solid Tumors

Phase 1 Completed 47 enrolled M.D. Anderson Cancer Center Alaunos Therapeutics · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary Objectives: 1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors. 2. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks. Secondary Objective: 1\. To determine the anti-tumor effects of ZIO-101.

Timeline

Start: 2005-05
Primary completion: 2008-04
Completion: 2008-04

Publications

Results Tsimberidou AM, Camacho LH, Verstovsek S, Ng C, Hong DS, Uehara CK, Gutierrez C, Daring S, Stevens J, Komarnitsky PB, Schwartz B, Kurzrock R. A phase I clinical trial of darinaparsin in patients with refractory solid tumors. Clin Cancer Res. 2009 Jul 15;15(14):4769-76. doi: 10.1158/1078-0432.CCR-08-2984. Epub 2009 Jul 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darinaparsin	Small molecule	78 mg/m2	Intravenous
Subject	Darinaparsin	Small molecule	109 mg/m2	Intravenous
Subject	Darinaparsin	Small molecule	153 mg/m2	Intravenous
Subject	Darinaparsin	Small molecule	214 mg/m2	Intravenous
Subject	Darinaparsin	Small molecule	300 mg/m2	Intravenous
Subject	Darinaparsin	Small molecule	420 mg/m2	Intravenous
Subject	Darinaparsin	Small molecule	500 mg/m2	Intravenous
Subject	Darinaparsin	Small molecule	588 mg/m2	Intravenous

Phase I Trial of ZIO-101 in Patients With Solid Tumors

Summary

Timeline

Publications

Drugs

Indications