A Phase 1 Study of S-3304 in Patients With Solid Tumors

Phase 1 Completed 32 enrolled Shionogi

Non-randomizedSequentialOpen-labelTreatment

Summary

To determine the maximum tolerated dose and safety profile of S-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. To determine the pharmacokinetic profile of S-3304 in this patient population

Timeline

Start: 2001-11
Primary completion: 2003-02-13
Completion: 2003-03-12

Publications

Results Chiappori AA, Eckhardt SG, Bukowski R, Sullivan DM, Ikeda M, Yano Y, Yamada-Sawada T, Kambayashi Y, Tanaka K, Javle MM, Mekhail T, O'bryant CL, Creaven PJ. A phase I pharmacokinetic and pharmacodynamic study of s-3304, a novel matrix metalloproteinase inhibitor, in patients with advanced and refractory solid tumors. Clin Cancer Res. 2007 Apr 1;13(7):2091-9. doi: 10.1158/1078-0432.CCR-06-1586.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	S-3304	Small molecule	800 mg	Oral
Subject	S-3304	Small molecule	1600 mg	Oral
Subject	S-3304	Small molecule	2400 mg	Oral
Subject	S-3304	Small molecule	3200 mg	Oral

A Phase 1 Study of S-3304 in Patients With Solid Tumors

Summary

Timeline

Publications

Drugs

Indications