Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma Publication Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma The purpose of this study was to characterize the pharmacokinetics of oral trametinib, a first in…CertaraApril 1, 2016
Immune Cell-based Screening Assay for Response to Anticancer Agents: Applications in Pharmacogenomics Publication Immune Cell-based Screening Assay for Response to Anticancer Agents: Applications in Pharmacogenomics CertaraFebruary 26, 2016
Factors Influencing the Central Nervous System Distribution of a Novel Phosphoinositide 3-Kinase/Mammalian Target of Rapamycin Inhibitor GSK2126458: Implications for Overcoming Resistance with Combination Therapy for Melanoma Brain Metastases Publication Factors Influencing the Central Nervous System Distribution of a Novel Phosphoinositide 3-Kinase/Mammalian Target of Rapamycin Inhibitor GSK2126458: Implications for Overcoming Resistance with Combination Therapy for Melanoma Brain Metastases CertaraFebruary 1, 2016
Population PK & Dosing Implications for Cobimetinib in Cancer Patients Publication Population PK & Dosing Implications for Cobimetinib in Cancer Patients A population pharmacokinetic model was developed for cobimetinib in cancer patients. Covariates had minimal impact…CertaraNovember 1, 2015
Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients Publication Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients The published OS model and resultant simulations can be leveraged to support Phase II design…CertaraSeptember 1, 2015
Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients Publication Population Pharmacokinetic Modeling of Motesanib and Its Active Metabolite, M4, in Cancer Patients Motesanib is a small molecule and potent multikinase inhibitor with antiangiogenic and antitumor activity. Population…CertaraJuly 23, 2015
Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment Publication Population Pharmacokinetic Analysis of Thrombomodulin Alfa to Support Dosing Rationale in Patients with Renal Impairment Thrombomodulin alfa is a soluble recombinant human thrombomodulin that was reported to enhance the reversal…CertaraMay 1, 2015
Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer Publication Onartuzumab with or without Bevacizumab in Combination with Weekly Paclitaxel Does Not Prolong QTc or Adversely Affect Other ECG Parameters in Patients with Locally Recurrent or Metastatic Triple-negative Breast Cancer The purpose of this study was to examine the potential effect of onartuzumab, when administered…CertaraDecember 17, 2014
Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival Publication Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival Modeling and simulation is proposed to support drug development phase transitions in oncology. Longitudinal tumor-size…CertaraAugust 1, 2014
Model-based Meta-analysis for Quantifying Paclitaxel Dose Response in Cancer Patients Publication Model-based Meta-analysis for Quantifying Paclitaxel Dose Response in Cancer Patients Model-based meta-analysis of dose response is a sophisticated method to guide dose and regimen selection.…CertaraMay 21, 2014