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ANNOUNCE: A randomized, placebo (PBO)-controlled, double-blind, phase (Ph) III trial of doxorubicin (dox) + olaratumab versus dox + PBO in patients (pts) with advanced soft tissue sarcomas (STS).
LBA3Background: Dox is standard therapy in STS. In a Ph 2 trial, olaratumab (a human IgG1 antibody targeting PDGFRα) + dox improved overall survival (OS) and progression-free survival (PFS) vs dox....
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Population Pharmacokinetic Modeling of Olaratumab, an Anti-PDGFRα Human Monoclonal Antibody, in Patients with Advanced and/or Metastatic Cancer
Background and ObjectivesOlaratumab is a recombinant human monoclonal antibody that binds to platelet-derived growth factor receptor-α (PDGFRα). In a randomized phase II study, olaratumab plusExpand
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Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial.
Importance Patients with advanced soft tissue sarcoma (STS) have a median overall survival of less than 2 years. In a phase 2 study, an overall survival benefit in this population was observed withExpand
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Optimal sampling of antipsychotic medicines: a pharmacometric approach for clinical practice.
AIM To determine optimal sampling strategies to allow the calculation of clinical pharmacokinetic parameters for selected antipsychotic medicines using a pharmacometric approach. METHODS This studyExpand
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Exposure–response relationship of olaratumab for survival outcomes and safety when combined with doxorubicin in patients with soft tissue sarcoma
PurposeOlaratumab is a recombinant human IgG1 monoclonal antibody against PGDFRα. Olaratumab plus doxorubicin improved survivalversus doxorubicin in an open-label, randomised phase 2 soft tissueExpand
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Solving delay differential equations in S-ADAPT by method of steps
S-ADAPT is a version of the ADAPT program that contains additional simulation and optimization abilities such as parametric population analysis and a solver for delay differential equations (DDEs). Expand
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Systematic Modeling and Design Evaluation of Unperturbed Tumor Dynamics in Xenografts
Xenograft mice are largely used to evaluate the efficacy of oncological drugs during preclinical phases of drug discovery and development. Mathematical models provide a useful tool to quantitativelyExpand
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Lifespan Based Pharmacokinetic-Pharmacodynamic Model of Tumor Growth Inhibition by Anticancer Therapeutics
Accurate prediction of tumor growth is critical in modeling the effects of anti-tumor agents. Popular models of tumor growth inhibition (TGI) generally offer empirical description of tumor growth. WeExpand
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A phase Ib study evaluating olaratumab in combination with nab-paclitaxel and gemcitabine in first-line treatment of metastatic pancreatic cancer.
330Background: Increased platelet-derived growth factor receptor alpha (PDGFRα) expression is linked to epithelial-mesenchymal transition in pancreatic cancer. Olaratumab (O) is a fully humanExpand
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M-054 Model Based Development Strategies for Covalent Molecules
Objectives: Covalent binding mechanisms offer unique opportunities in drug development, and have been utilized to overcome various development challenges, such as dosing frequency, poorExpand