First-in-Human Studies (Phase I Trials)
- A phase I trial to determine the safety, tolerability, and maximum tolerated dose of deforolimus in patients with advanced malignancies. (Hartford et al., Clin Cancer Res 15:1428-1434, 2009)
- A phase I study of continuous infusion cilengitide in patients with solid tumors. (O'Donnell et al., Invest New Drugs 30:604-610, 2012)
Combination and Drug-Drug Interaction Studies
- A phase I study of sirolimus and bevacizumab in patients with advanced malignancies. (Cohen et al., Eur J Cancer 47:1484-1489, 2011)
- Two drug interaction studies of sirolimus in combination with sorafenib or sunitinib in patients with advanced malignancies. (Gangadhar et al., Clin Cancer Res 17:1956-1963, 2011)
- Inconsistent labeling of food effect for oral agents across therapeutic areas: differences between oncology and non-oncology products. (Kang, Ratain, Clin Cancer Res 16:4446-4451, 2010)
- Flushing oral oncology drugs down the toilet. (Ratain, J Clin Oncol 29:3958-3959, 2011)
- Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301. (Miller et al., J Clin Oncol 27:1800-1805, 2009)
- Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. (Innocenti et al., J Clin Oncol 22:1382-1388, 2006)
- Pharmacogenetics and pharmacogenomics of anticancer agents. (Huang et al., CA Cancer J Clin 59:42-55, 2009)
- Successful implementation of the randomized discontinuation trial design: an application to the study of the putative antiangiogenic agent carboxyaminoimidazole in renal cell carcinoma—CALGB 69901. (Stadler et al., J Clin Oncol 23:3726-3732, 2005)
- Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. (Ratain et al., J Clin Oncol 24:2505-2512, 2006)
- Randomized phase II trials: a long-term investment with promising returns. (Sharma et al., J Natl Cancer Inst 103:1093-1100, 2011)
- Dose-escalation models for combination phase I trials in oncology. (Hamberg et al., Eur J Cancer 46:2870-2878, 2010)
Pharmacodynamic Biomarker Studies
- Ambulatory monitoring detects sorafenib-induced blood pressure elevations on the first day of treatment. (Maitland et al., Clin Cancer Res 15:6250-6257, 2009)
