Agent study

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An agent study is a part of a clinical trial that tests the chemotherapeutic properties of a specific substance. More specifically, an agent study is used to detect whether or not a substance can prevent or inhibit cancer. [1] In a clinical trial, researchers perform multiple studies in order to test the potential of new cancer drugs. An agent study helps determine the potential of a substance to inhibit cancer, before more studies are done in order to further knowledge of this potential.

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.

Chemotherapy treatment of cancer with one or more cytotoxic anti-neoplastic drugs

Chemotherapy is a type of cancer treatment that uses one or more anti-cancer drugs as part of a standardized chemotherapy regimen. Chemotherapy may be given with a curative intent, or it may aim to prolong life or to reduce symptoms. Chemotherapy is one of the major categories of the medical discipline specifically devoted to pharmacotherapy for cancer, which is called medical oncology.

Cancer disease of uncontrolled, unregulated and abnormal cell growth

Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal bleeding, prolonged cough, unexplained weight loss and a change in bowel movements. While these symptoms may indicate cancer, they may have other causes. Over 100 types of cancers affect humans.

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Cytotoxic vs. Cytostatic Agents

Agent studies are used to determine whether a substance exhibits cytotoxicity or cytostasis. A cytotoxic agent will shrink a tumor, while, a cytostatic agent slows or stops tumor growth and metastases. It is important to determine which of these effects an agent poses so that a proper clinical trial can be designed. For example, a study with a cytotoxic agent will look for tumor shrinkage vs. dose. It is much harder to develop a clinical trial for a cytostatic agent. [2]

Cytotoxicity is the quality of being toxic to cells. Examples of toxic agents are an immune cell or some types of venom, e.g. from the puff adder or brown recluse spider.

Cytostasis is the inhibition of cell growth and multiplication. Cytostatic refers to a cellular component or medicine that inhibits cell growth.

Phase I Clinical Trials

Phase I trials are used to determine the maximum tolerated dose of an agent. This dose is then used in the Phase II trials. Maximum tolerated dose is based on the measured toxicity in cytotoxic agents. Cytostatic agents have been demonstrated to show biologic effects while also being nontoxic. It is recommended that cytostatic agent trials determine toxicity as well as evaluation of a biologic end point in response to different doses. [2]

Synonym: Chemoprevention study

Related Research Articles

Experimental cancer treatments are non-medical therapies intended to treat cancer by improving on, supplementing or replacing conventional methods. Experimental cancer treatments cannot make medical claims. The term experimental cancer treatment could thus be substituted for "non FDA approved cancer treatment."

The therapeutic index is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxicity. The related terms therapeutic window or safety window refer to a range of doses which optimize between efficacy and toxicity, achieving the greatest therapeutic benefit without resulting in unacceptable side-effects or toxicity.

Ranpirnase

Ranpirnase is a ribonuclease enzyme found in the oocytes of the Northern Leopard Frog. Ranpirnase is a member of the pancreatic ribonuclease protein superfamily and degrades RNA substrates with a sequence preference for uracil and guanine nucleotides. Along with amphinase, another leopard frog ribonuclease, ranpirnase has been studied as a potential cancer treatment due to its unusual mechanism of cytotoxicity tested against tumor cells.

Temsirolimus chemical compound

Temsirolimus is an intravenous drug for the treatment of renal cell carcinoma (RCC), developed by Wyeth Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in late May 2007, and was also approved by the European Medicines Agency (EMEA) on November 2007. It is a derivative and prodrug of sirolimus and is sold as Torisel.

Apatinib

Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2. It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. This agent also mildly inhibits c-Kit and c-SRC tyrosine kinases.

A phosphoinositide 3-kinase inhibitor is a class of medical drug that functions by inhibiting one or more of the phosphoinositide 3-kinase enzymes, which are part of the PI3K/AKT/mTOR pathway, an important signalling pathway for many cellular functions such as growth control, metabolism and translation initiation. Within this pathway there are many components, inhibition of which may result in tumor suppression. These anti-cancer drugs are examples of targeted therapy.

NAMI-A

NAMI-A and KP1019 are two ruthenium anticancer agents that have entered clinical trials. Contrary to what can be found in some papers, "the nickname NAMI is not the acronym of “New Anticancer Metastasis Inhibitor”, but has a much more prosaic origin. It was created by a student as a short-form name of the chemical formula of the complex: “NA” comes from the symbol for sodium and “MI” from the word imidazole. The corresponding imidazolium salt was simply called NAMI-A to signify that it was an upgraded version of the prototype NAMI".

Nintedanib chemical compound

Nintedanib, marketed under the brand names Ofev and Vargatef, is an oral medication used for the treatment of idiopathic pulmonary fibrosis and along with other medications for some types of non-small-cell lung cancer.

Angiokinase inhibitors are a new therapeutic target for the management of cancer. They inhibit tumour angiogenesis, one of the key processes leading to invasion and metastasis of solid tumours, by targeting receptor tyrosine kinases. Examples include nintedanib, afatinib and motesanib.

Cariporide chemical compound

Cariporide is a selective Na+/H+ exchange inhibitor. Cariporide has been shown to actively suppress the cell death caused by oxidative stress.

Beloranib chemical compound

Beloranib is a former drug candidate for the treatment of obesity. It was discovered by CKD Pharmaceuticals and its clinical development was led by Zafgen. Drug development was halted in 2016 after deaths during clinical trials.

Fostamatinib chemical compound

Fostamatinib, sold under the brand name Tavalisse, is a medication approved by the U.S. Food and Drug Administration since 2018 for the treatment of chronic immune thrombocytopenia (ITP). The drug is administered orally as a disodium hexahydrate salt, and is a prodrug of the active compound tamatinib (R-406), which is an inhibitor of the enzyme spleen tyrosine kinase (Syk), hence it is an syk inhibitor.

The phases of clinical research are the steps in which scientists do experiments with a health intervention in an attempt to find enough evidence for a process which would be useful as a medical treatment. In the case of pharmaceutical study, the phases start with drug design and drug discovery then proceed on to animal testing. If this is successful, they begin the clinical phase of development by testing for safety in a few human subjects and expand to test in many study participants to determine if the treatment is effective.

Brivanib alaninate chemical compound

Brivanib alaninate (INN/USAN) also known as BMS-582664 is an investigational, anti-tumorigenic drug for oral administration. The drug is being developed by Bristol-Myers Squibb for the treatment of hepatocellular carcinoma or HCC, the most common type of liver cancer.

Demcizumab is a humanized monoclonal antibody which is used to treat patients with pancreatic cancer or non-small cell lung cancer. Demcizumab has completed phase 1 trials and is currently undergoing phase 2 trials. Demcizumab was developed by OncoMed Pharmaceuticals in collaboration with Celgene.

Arabinopyranosyl-<i>N</i>-methyl-<i>N</i>-nitrosourea chemical compound

Arabinopyranosyl-N-methyl-N-nitrosourea, also known as Aranose (Араноза) is a cytostatic anticancer chemotherapeutic drug of an alkylating type. Chemically it is a nitrosourea derivative. It was developed in the Soviet Union in the 1970s. It was claimed by its developers that its advantages over other nitrosoureas are a relatively low hematological toxicity and a wider therapeutic index, which allows for its outpatient administration.

Ribociclib chemical compound

Ribociclib is an inhibitor of cyclin D1/CDK4 and CDK6, and is used for the treatment of certain kinds of breast cancer. It is also being studied as a treatment for other drug-resistant cancers. It was developed by Novartis and Astex Pharmaceuticals.

Niraparib chemical compound

Niraparib is an orally active small molecule PARP inhibitor developed by Tesaro to treat ovarian cancer.

Loncastuximab tesirine or ADCT-402 is an antibody-drug conjugate (ADC) composed of a humanized antibody targeting the protein CD19, which is expressed in a wide range of B cell hematological tumors. The experimental drug, developed by ADC Therapeutics is being tested in clinical trials for the treatment of B-cell non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukemia (ALL).

References

  1. glossary Archived July 18, 2007, at the Wayback Machine .
  2. 1 2 Korn, Edward L.; Susand G. Arbuck; James M. Pluda; Richard Simon; Richard S. Kaplan; Michaela C. Christian (2001-01-01). "Clinical Trial Designs for Cytostatic Agents: Are New Approaches Needed?". Journal of Clinical Oncology. 19 (1): 265–272. doi:10.1200/jco.2001.19.1.265. PMID   11134222 . Retrieved 2013-11-25.

See also