Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor

Phase 1 Completed 204 enrolled M.D. Anderson Cancer Center

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of valproic acid in combination with either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide, sorafenib, or SU011248 (sunitinib malate) that can be given to patients with advanced cancer. The safety of each combination of the study drugs will be studied as well.

Timeline

Start: 2007-06
Primary completion: 2012-10
Completion: —

Publications

Kurzrock R, Atkins J, Wheler J, Fu S, Naing A, Busaidy N, Hong D, Sherman S. Tumor marker and measurement fluctuations may not reflect treatment efficacy in patients with medullary thyroid carcinoma on long-term RET inhibitor therapy. Ann Oncol. 2013 Sep;24(9):2256-61. doi: 10.1093/annonc/mdt177. Epub 2013 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	100 mg	Oral
Subject	Lapatinib	Small molecule	1000 mg	Oral
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Sorafenib	Small molecule	400 mg	Oral
Subject	Sunitinib	Small molecule	25 mg	Oral
Subject	Valproic Acid	Small molecule	40 mg/kg	Oral
Subject	dasatinib anhydrous	Small molecule	50 mg	Oral

Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor

Summary

Timeline

Publications

Drugs

Indications