scholarly journals Platinum-based anticancer drugs encapsulated liposome and polymeric micelle formulation in clinical trials

2016 ◽  
Vol 4 (1) ◽  
pp. 1 ◽  
Author(s):  
Zhou Hang ◽  
Matthew A Cooper ◽  
Zyta M Ziora
Keyword(s):  
Clinical Trials ◽  
Anticancer Drugs ◽  
Polymeric Micelle

scholarly journals A Review of Repurposed Cancer Drugs in Clinical Trials for Potential Treatment of COVID-19

Pharmaceutics ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 815
Author(s):  
Bárbara Costa ◽  
Nuno Vale
Keyword(s):  
Clinical Trials ◽  
Anticancer Drugs ◽  
Clinical Management ◽  
Scientific Discovery ◽  
Immune Dysfunction ◽  
Potential Treatment ◽  
Medical Treatments ◽  
Prevention And Treatment ◽  
Rapid Pace ◽  
Effective Drugs

The pandemic of the coronavirus disease 2019 (COVID-19) represents an unprecedented challenge to identify effective drugs for prevention and treatment. While the world’s attention is focused on news of COVID-19 vaccine updates, clinical management still requires improvement. Due to the similarity of cancer-induced inflammation, immune dysfunction, and coagulopathy to COVID-19, anticancer drugs, such as Interferon, Pembrolizumab or Bicalutamide, are already being tested in clinical trials for repurposing, alone or in combination. Given the rapid pace of scientific discovery and clinical data generated by the large number of people rapidly infected, clinicians need effective medical treatments for this infection.

scholarly journals Age disparity between a cancer population and participants in clinical trials submitted as a new drug application of anticancer drugs in Japan

Cancer ◽  
2007 ◽  
Vol 109 (12) ◽  
pp. 2541-2546 ◽  
Author(s):  
Akiko Hori ◽  
Taro Shibata ◽  
Masahiro Kami ◽  
Eiji Kusumi ◽  
Hiroto Narimatsu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Anticancer Drugs ◽  
Drug Application ◽  
New Drug ◽  
New Drug Application ◽  
Age Disparity

scholarly journals Healthy Volunteer Studies in the Development of Anticancer Drugs with Genotoxic Findings

2021 ◽  
Author(s):  
Grace Omes-Smit ◽  
Marjolein Garsen ◽  
Alex Zwiers
Keyword(s):  
Clinical Trials ◽  
Anticancer Drugs ◽  
Exposure Dose ◽  
Cell System ◽  
General Information ◽  
European Medicines Agency ◽  
Genetic Toxicology ◽  
Toxicology Screening ◽  
Available Information ◽  
The Eu

Abstract Background Recent scientific advances in cancer research have led to the development of immunomodulatory and molecularly targeted drugs with better safety profiles than chemotherapeutics, which makes it possible to include healthy volunteers (HVs) in clinical trials. In this study, we aimed to identify the number of marketing authorization applications (MAAs) that enrolled HVs in a clinical trial and to identify the number of anticancer drugs that were given to HVs despite a positive genotoxic finding. In addition, we evaluated the dose of anticancer drugs administered to HVs and the justification for proceeding with HV studies despite a positive genotoxic finding. Methods Publicly available information from the European Medicines Agency (EMA) website was used for this study. Anticancer drugs were identified using the human medicines highlights published by EMA between January 2010 and December 2019. EPARs were used to collect general information of the anticancer drugs, details on genotoxicity studies, and the enrollment of HVs in clinical trials. Results We identified 71 MAAs for small molecule anticancer drugs with a positive or negative CHMP opinion in the EU. Forty-eight anticancer drugs were studied in HVs, of which 12 anticancer drugs were administered to HVs despite positive genotoxic findings in the standard battery. Systematic and extensive genetic toxicology screening demonstrated the absence of genotoxic risks to the cell system. Conclusion We showed that despite a positive genotoxic finding, comprehensive genetic toxicology testing demonstrated the absence of risks to the cell system at the human exposure dose. Therefore, these anticancer drugs posed no harm to HVs.

scholarly journals Bioactive Olivacine Derivatives—Potential Application in Cancer Therapy

Biology ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 564
Author(s):  
Beata Tylińska ◽  
Benita Wiatrak
Keyword(s):  
Clinical Trials ◽  
Biological Activity ◽  
Growth Factors ◽  
Anticancer Drugs ◽  
Inhibition Of Growth ◽  
Structure Activity ◽  
Sar Analysis ◽  
New Anticancer Drugs

 Olivacine and its derivatives are characterized by multidirectional biological activity. Noteworthy is their antiproliferative effect related to various mechanisms, such as inhibition of growth factors, enzymes, kinases and others. The activity of these compounds was tested on cell lines of various tumors. In most publications, the most active olivacine derivatives exceeded the effects of doxorubicin (a commonly used anticancer drug), so in the future, they may become the main new anticancer drugs. In this publication, we present the groups of the most active olivacine derivatives obtained. In this work, the in vitro and in vivo activity of olivacine and its most active derivatives are presented. We describe olivacine derivatives that have been in clinical trials. We conducted a structure–activity relationship (SAR) analysis that may be used to obtain new olivacine derivatives with better properties than the available anticancer drugs. 

Publication statuses of clinical trials supporting immune checkpoint inhibitors recently approved by the United States Food and Drug Administration: A meta-epidemiological investigation.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 89-89
Author(s):  
Kenji Omae ◽  
Yuki Kataoka ◽  
Yasushi Tsujimoto ◽  
Yusuke Tsutsumi ◽  
Shunichi Fukuhara ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Anticancer Drugs ◽  
Drug Administration ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Food And Drug Administration ◽  
The United States ◽  
Publication Rate ◽  
Significant Difference

89 Background: The low trial publication rate for drugs approved by the U.S. Food and Drug Administration (FDA) and the discrepancies between data submitted to the FDA and data found in published trials remain concerning. We investigated the publication statuses of trials of recently approved anticancer drugs documented by the FDA, especially immune checkpoint inhibitors (ICPis), to determine the discrepancies between data submitted to the FDA and those published. Methods: We identified all ICPis approved between 2011 (the year the first ICPi was approved by the FDA) and 2014 (selected to assure a follow-up of at least 3 years post-approval). We assessed the clinical trials for each drug indication and matched each trial with publications in the literature. The primary outcome was the publication status 2 years post-approval. We examined the association between time to publication and drug type using a multilevel Cox regression model, adjusted for clustering within drug indications and individual covariates. Results: Between 2011 and 2014, 36 anticancer drugs including 3 ICPis were newly approved by the FDA. Of 19 trials investigating the 3 ICPis, 11 (58%) were published within 2 years post-approval. We randomly selected 10 of the 33 remaining anticancer drugs; 68 of 101 trials investigating these drugs (67%) were published. Overall, the publication rate was 66% at 2 years post-approval with a median time to publication of 2.3 years. There was no significant difference in time to trial publication between ICPis and other anticancer drugs (adjusted hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.8–1.7; P = 0.55); however, non-ICPIs investigated specifically in randomized phase 2 or 3 trials were significantly more likely to be published earlier than ICPis (adjusted HR, 7.4; 95% CI, 1.8–29.5; P = 0.005). Conclusions: One in three trials of the newest anticancer drugs remained unpublished 2 years after FDA approval. The ICPi publication rate was similar to that of other anticancer drugs. (Protocol registration: UMIN000030475).

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