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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....
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 plus… Expand
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 with… Expand
Optimal sampling of antipsychotic medicines: a pharmacometric approach for clinical practice.
- V. Perera, R. Bies, +6 authors A. Forrest
- British journal of clinical pharmacology
- 1 October 2014
AIM To determine optimal sampling strategies to allow the calculation of clinical pharmacokinetic parameters for selected antipsychotic medicines using a pharmacometric approach. METHODS This study… Expand
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 tissue… Expand
Solving delay differential equations in S-ADAPT by method of steps
- R. J. Bauer, Gary Mo, W. Krzyzanski
- Mathematics, Computer Science
- Comput. Methods Programs Biomed.
- 1 September 2013
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
Systematic Modeling and Design Evaluation of Unperturbed Tumor Dynamics in Xenografts
- Zinnia P. Parra-Guillen, V. Mangas-Sanjuan, +5 authors J. Wallin
- Mathematics, Medicine
- The Journal of Pharmacology and Experimental…
- 1 July 2018
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 quantitatively… Expand
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. We… Expand
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 human… Expand
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, poor… Expand