Biomarkers-guided targeted drugs: new clinical trials design and practice necessity

2011 ◽  
pp. 30-41
Author(s):  
Ming-Wen An ◽  
Sumithra J Mandrekar ◽  
Daniel J Sargent
Keyword(s):  
Clinical Trials ◽  
Targeted Drugs ◽  
Design And Practice

Personalizing Oncology: Perspectives and Prospects

2013 ◽  
Vol 31 (15) ◽  
pp. 1904-1911 ◽  
Author(s):  
John Mendelsohn
Keyword(s):  
Clinical Trials ◽  
Molecular Targets ◽  
Targeted Drugs ◽  
Genetic Aberrations ◽  
Patients With Cancer ◽  
Reasonable Cost ◽  
Before And After ◽  
Cancer Medicine ◽  
And Performance ◽  
Selection Of

This article provides an overview of the research, beginning a century ago, that has led to the current use of genomically informed methods for selection of targeted therapies to treat individual patients with cancer—so-called precision cancer medicine. Until 1980, most research on cancer therapy was not targeted in the sense we use the word today. Since then, there has been an acceleration in research identifying genetic and molecular targets and in clinical trials using biomarkers that identify the presence of genetic or molecular markers in a patient's cancer to select appropriate targeted therapy. This approach has been made possible by increased knowledge of the genetic pathogenesis of cancer and by increased capacity to sequence genes and genomes in clinically useful timeframes and at a reasonable cost. However, many challenges and pitfalls remain in selecting optimal targets, interpreting data on genetic aberrations, designing effective targeted drugs and antibodies, dealing with resistance to treatments, identifying appropriate combinations of therapies, and performing the complex clinical trials that are required. Future clinical research with experimental targeted agents is likely to be more informative because of appropriate preselection of patients enrolled onto trials and performance of genetic and molecular studies on specimens of a patient's cancer before and after treatment.

scholarly journals Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov

2015 ◽  
Vol 18 (8) ◽  
pp. 796-805 ◽  
Author(s):  
Alexandre Vivot ◽  
Jacques Li ◽  
Jean-David Zeitoun ◽  
Samia Mourah ◽  
Perrine Crequit ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Drugs ◽  
Inclusion Criteria

scholarly journals Mitochondria-Targeted Drugs

2019 ◽  
Vol 12 (3) ◽  
pp. 202-214 ◽  
Author(s):  
Roman A. Zinovkin ◽  
Andrey A. Zamyatnin
Keyword(s):  
Clinical Trials ◽  
Animal Models ◽  
Targeted Drugs ◽  
Molecular Pharmacology ◽  
National Library ◽  
Lipophilic Cations ◽  
Wide Range ◽  
Metabolic Conditions ◽  
Available Information

Background: Targeting of drugs to the subcellular compartments represents one of the modern trends in molecular pharmacology. The approach for targeting mitochondria was developed nearly 50 years ago, but only in the last decade has it started to become widely used for delivering drugs. A number of pathologies are associated with mitochondrial dysfunction, including cardiovascular, neurological, inflammatory and metabolic conditions. Objective: This mini-review aims to highlight the role of mitochondria in pathophysiological conditions and diseases, to classify and summarize our knowledge about targeting mitochondria and to review the most important preclinical and clinical data relating to the antioxidant lipophilic cations MitoQ and SkQ1. Methods: This is a review of available information in the PubMed and Clinical Trials databases (US National Library of Medicine) with no limiting period. Results and Conclusion: Mitochondria play an important role in the pathogenesis of many diseases and possibly in aging. Both MitoQ and SkQ1 have shown many beneficial features in animal models and in a few completed clinical trials. More clinical trials and research efforts are needed to understand the signaling pathways influenced by these compounds. The antioxidant lipophilic cations have great potential for the treatment of a wide range of pathologies.

scholarly journals Emerging Therapeutic Drugs in Metastatic Triple-Negative Breast Cancer

2021 ◽  
Vol 15 ◽  
pp. 117822342110024
Author(s):  
Élia Cipriano ◽  
Alexandra Mesquita
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Triple Negative Breast Cancer ◽  
Systemic Chemotherapy ◽  
Triple Negative ◽  
Treatment Options ◽  
Phase Iii ◽  
Molecular Testing ◽  
Targeted Drugs ◽  
Metastatic Setting

Metastatic triple-negative breast cancer (TNBC) is a heterogeneous disease with a poor prognosis and currently with few treatment options. Treatment of these patients is highly based on systemic chemotherapy. Some targeted drugs were recently approved for these patients: two poly(ADP-ribose) polymerase inhibitors in patients with germline BRCA1/2 mutations (olaparib and talazoparib), immune checkpoint inhibitors in association with chemotherapy if programmed death-ligand 1 positive (atezolizumab plus nabpaclitaxel and pembrolizumab plus chemotherapy [nabpaclitaxel, paclitaxel, and carboplatin plus gemcitabine]), and an antibody-drug conjugate sacituzumab-govitecan in heavily pretreated patients (at least 2 previous lines for the metastatic setting). Combinations using these and other targeted treatment options are under investigation in early and late clinical trials, and we will probably have some practice-changing results in the new future. Other targeted drugs explored in phase II and phase III clinical trials are PI3K/AKT pathway inhibitors and androgen receptor antagonists in patients with alterations in these signaling pathways. The definition of molecular subtypes has been essential for the development of these treatment strategies. Soon, the treatment of metastatic TNBC could be based on personalized medicine using molecular testing for targeted drugs instead of only systemic chemotherapy. The authors present a review of emerging treatment options in metastatic TNBC, focusing on targeted drugs, including the recent data published in 2020.

scholarly journals Imposing Phase II and Phase III Clinical Trials of Targeted Drugs for Glioblastoma: Current Status and Progress

2021 ◽  
Vol 11 ◽  
Author(s):  
Yaning Wang ◽  
Wanqi Chen ◽  
Yixin Shi ◽  
Chengrui Yan ◽  
Ziren Kong ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Phase Iii ◽  
Current Status ◽  
Future Research ◽  
Targeted Drugs ◽  
Comprehensive Overview ◽  
Phase Iii Clinical Trials ◽  
Degree Of Malignancy ◽  
Primary Intracranial Tumor

The most common primary intracranial tumor is glioma, among which glioblastoma (GBM) has the worst prognosis. Because of the high degree of malignancy of GBM and frequent recurrence after surgery, postoperative therapy, including chemotherapy, radiotherapy, targeted therapy, and immunotherapy, is particularly important. A wide variety of targeted drugs have undergone phase III clinical trials for patients with GBM, but these drugs do not work for all patients, and few patients in these trials have prolonged overall survival. In this review, some imposing phase III clinical trials of targeted drugs for glioma are introduced, and some prospective phase II clinical trials that have been completed or are in progress are summarized. In addition, the mechanisms of these drugs are briefly introduced, and deficiencies of these clinical trials are analyzed. This review aims to provide a comprehensive overview of current research on targeted drugs for glioma to clarify future research directions.

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