OHSU

Clinical Trial Support

Overview

The Knight Diagnostic Laboratories are CLIA-licensed and CAP-certified. In addition, we adhere to all GLP & GCP guidelines related to the conduct of clinical trials. During the past decade, KDL Directors and staff have provided diagnostic support for clinical trials sponsored by over a dozen pharmaceutical and biotechnology companies. Our experience and expertise to the development and validation of new assays/companion diagnostics makes us excellent partners for oncology trials in the area of personalized cancer care.

Publications related to some of the clinical trials that have been supported by KDL personnel:

1.Heinrich MC, Corless CL, Demetri GD, Blanke CD, von Mehren M, Joensuu H, McGreevey LS, Chen C-J, Kiese B, Eisenberg B, Roberts PJ, Singer S, Fletcher CDM, Silberman S, Dimitrijevic S, Fletcher JA.Kinase mutations and imatinib mesylate response in patients with metastatic gastrointestinal stromal tumor. J Clin Onc 21:4342-4349, 2003.

2.McArthur GA, Demetri GD, Van Oosterom A, Heinrich MC, Corless CL, Nikolova Z, Dimitrijevic S, Fletcher JA. Molecular and clinical analysis of locally advanced dermatofibrosarcoma protuberans treated with imatinib. J Clin Onc 23:866-873, 2005.

3.HeinrichMC, McArthur GA, DemetriGD, JoensuuH, BonoP, HerrmanR, HirteH, GianniL, KoslinDB, CorlessCL, DirnhoferS, van Oosterom A, NikolovaZ, DimitrijevicS, FletcherJA, for the Imatinib Target Exploration Consortium (ITEC Study B2225). Clinical and molecular studies of the effect of imatinib on advanced aggressive fibromatosis (desmoid tumor). J Clin Onc 24:1195-1202, 2006.

4.Heinrich MC, Corless CL, Blanke CD, Demetri, GD, Joensuu H, Roberts PJ, Eisenberg B, von Mehren M, Fletcher CDM, Sandau K, McDougall K, Ou WB, Chen C-J, Fletcher JA.Molecular correlates of imatinib resistance in gastrointestinal stromal tumors. J Clin Onc 24:4764-74, 2006.

5.Heinrich MC, Joensuu H, Demetri GD, Corless CL, Apperley J, Fletcher JA, Soulieres D, Dirnhofer S, Harlow A, Town A, McKinley A, Supple SG, Seymour J, Di Scala L, van Oosterom A, Herrmann R, Nikolova Z, McArthur AG; for the Imatinib Target Exploration Consortium Study B2225. Phase II, Open-label study evaluating the activity of imatinib in treating life-threatening malignancies known to be associated with imatinib-sensitive tyrosine kinases. Clin Can Res 14:2717-2725, 2008.

6.Heinrich MC, Owzar K, Corless CL, Hollis D, Borden EC, Fletcher CD, Ryan CW, von Mehren M, Blanke CD, Rankin C, Benjamin RS, Bramwell VH, Demetri GD, Bertagnolli MM, Fletcher JA. Correlation of kinase genotype and clinical outcome in the North American Intergroup Phase III trial of imatinib mesylate for treatment of advanced gastrointestinal stromal tumor: CALGB 150105 Study by Cancer and Leukemia Group B and Southwest Oncology Group. J Clin Oncol. 26(33):5360-7, 2008.

7.Heinrich MC, Maki RG, Corless CL, Antonescu CR, Harlow A, Griffith D, Town A, McKinley A, Ou WB, Fletcher JA, Fletcher CD, Huang X, Cohen DP, Baum CM, Demetri GD. Primary and secondary kinase genotypes correlate with the biological and clinical activity of sunitinib in imatinib-resistant gastrointestinal stromal tumor. J Clin Oncol. 26(33):5352-9, 2008.

8.Schittenhelm MM, Kollmannsberger C, Oechsle K, Harlow A, Morich J, Honecker F, Kurek R, Störkel S, Kanz L, Corless CL, Wong K-K, Bokemeyer C, Heinrich MC. Molecular determinants of response to matuzumab in combination with paclitaxel for patients with advanced non-small cell lung cancer. Mol Cancer Ther. 8:481-9, 2009.