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Scientific Accomplishments

Howard Bailey, MD – Chemoprevention Program

The 3P Lab developed and validated an LC/MS/MS analytical assay for a first in human clinical trial of UAB30. UAB30 is a novel retinoid being developed as a chemoprevention agent and a therapeutic agent for breast cancer.  The primary endpoint of this trial was to evaluate the single dose PK in normal volunteers, with the primary hypothesis that UAB30 would be orally available. This study demonstrated oral availability, dose proportionality as depicted below, primarily hepatic metabolism and a half-life of approximately eight hours for UAB30.

 

Significant Accomplishment - Howard Bailey

Kolesar JM, et al. A pilot, first-in-human, pharmacokinetic study of 9cUAB30 in healthy volunteers. Cancer Prev Res, 2010;3(12):1565-70. PMCID: PMC3204611. Supported by N01 CN35153. 

 

Means and Standard Error Bars of AUC and Cmax by UAB30 treatment group shown, along with fitted curves representing chosen models.

 

 

Brad Kahl, MD - Experimental Therapeutics Program 

The 3P Lab evaluated EGFR mutations in patients with the bronchioalveolar variant of non-small cell lung cancer being treated with cetuximab, with the trial demonstrating some single agent activity. The primary laboratory hypothesis was that cetuximab response would be predicted by EGFR mutation status.

 

Significant Accomplishments Kahl

Ramalingam SS, Lee JW, Belani CP, Aisner SC, Kolesar J, Howe C, Velasco MR, Schiller JH. Cetuximab for the treatment of advanced bronchioloalveolar carcinoma (BAC): an Eastern Cooperative Oncology Group phase II study (ECOG 1504). J Clin Oncol, 2011;29(13):1709-14. PMCID: PMC3107763. Supported by U10 CA210R76.

 

 

Glenn Liu, MD – Experimental Therapeutics Program

The 3P Lab developed and validated an LC/MS/MS (liquid chromatography tandem mass spectrometry) assay for the analysis of sunitinib and performed an ELISA assay for VEGF, which were utilized in NCI #7898, “Pharmacodynamic Study Using FLT PET/CT in Patients with Renal Cell Cancer and Other Solid Malignancies Treated with Sunitinib Malate.”

 

Taken from Liu, et al. Pharmacodynamic study using FLT PET/CT in patients with renal cell cancer and other solid malignancies treated with sunitinib malate. Clin Cancer Res, 2011;Dec 15;17(24):7634-44. Supported by U01 CA062491.

 

Multivariate analysis demonstrated that plasma VEGF levels independently predict tumor proliferation during sunitinib treatment. PK and PD parameters at time points throughout the sunitinib cycle are shown. Thin dotted lines show individual patient results. (ccRCC, clear cell renal cell carcinoma.)