Phase I Study of a Statin + Erlotinib for Advanced Solid Malignancies With Focus on Squamous Cell Carcinomas and NSCLC

Phase 1 Completed 24 enrolled Ottawa Hospital Research Institute Ozmosis Research Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the recommended phase II dose (RP2D) of rosuvastatin that can be given in combination with standard erlotinib treatment in patients with advanced incurable squamous cell cancer and NSCLC.

Timeline

Start: 2009-03
Primary completion: 2014-09
Completion: 2014-09

Publications

Results Goss GD, Jonker DJ, Laurie SA, Weberpals JI, Oza AM, Spaans JN, la Porte C, Dimitroulakos J. A phase I study of high-dose rosuvastatin with standard dose erlotinib in patients with advanced solid malignancies. J Transl Med. 2016 Mar 31;14:83. doi: 10.1186/s12967-016-0836-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Rosuvastatin	Small molecule	1 mg/kg	Oral
Subject	Rosuvastatin	Small molecule	2 mg/kg	Oral
Subject	Rosuvastatin	Small molecule	8 mg/kg	Oral

Phase I Study of a Statin + Erlotinib for Advanced Solid Malignancies With Focus on Squamous Cell Carcinomas and NSCLC

Summary

Timeline

Publications

Drugs

Indications