This trial is evaluating whether Binimetinib will improve 1 primary outcome and 7 secondary outcomes in patients with Cancer. Measurement will happen over the course of 2.5 years.
This trial requires 26 total participants across 2 different treatment groups
This trial involves 2 different treatments. Binimetinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
The majority of cancer patients are diagnosed with curable cancer with surgery, radiation, or other treatment options, such as chemotherapy, hormonal or biologic agents, radiation therapy, and immunotherapy. The type and location of the cancer also impacts the treatment that is most recommended for the patient.
Cancer is the result of a combination of genetic risk factors and environmental exposures. Smoking, a major environmental risk factor, may be associated with the increased risk of developing [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), colorectal cancer and cancer of the thyroid. Other environmental risks include sun exposure and UV radiation, diet, alcohol, and many recreational drugs. The exact mechanism by which lifestyle factors cause cancer is not entirely clear. Exposure to environmental agents may enhance or deregulate biological processes that otherwise occur randomly.
The term cancer means growth out of control. When we look at the human body and think about cancer, we often focus on its most obvious physical symptoms—the white blood cell counts, a person's weight, tumor size, bone density, and tumor location. These symptoms do not come from only the part of the body in which the cancer forms and begins to grow. Another term for a cancer is 'a disease or disorder which is not caused by infection, but whose most prominent sign and symptom are those involving the growth of tumours'.
The symptoms of cancer may indicate the cancer and depend on the type of cancer. A high fever raises the possibility of leukemia and some solid cancers (such as kidney cancer) may cause bone pain. It is prudent to consider all of the above symptoms and make the right diagnosis.
Treatment-related issues of prognosis and quality of life can significantly influence the patient's perception of cure. However, treatment-induced cure might still be possible, but much more likely to occur if tumour response to initial treatment were optimal.
Binimetinib is most commonly combined with other treatments, especially with temsirolimus. Some of its side effects may be alleviated by using a more selective CYP1A1 inhibitor such as astemizole or the newer and more specific CYP1A1 inhibitor afatinib.
The information that is provided in cancer and other diseases has drastically improved in recent years, it has become more accessible and there is so much more information available to the general public. If people were to read more about the latest research there is a possibility of them becoming aware of more risk factors and how to prevent themselves from getting cancer. Many people still do not have the knowledge to know how to prevent themselves.
Most binimetinib side effects were mild to moderate and mild/moderately reversible according to the FDA's recommendation. Many patients had no side effects on the first or second dose of binimetinib at the 240 mg dose. The most common side effects were fatigue, insomnia (<24%), headache, rash, nausea, diarrhea, abdominal pain, and constipation when binimetinib was discontinued. Some patients and people taking other medicines concurrently may not show the listed side effects; thus side effect results may be different in different people. Some of the side effects listed above may also be related to some of the diseases or medicines (mainly chemotherapy) that some people take concurrently.
Some of the factors that are thought to be significant or important in the development of cancer in most cases are genetic factors and environmental factors. Many of the human cancers are caused by mutational events that cause changes in the genes involved in cell growth and survival and the DNA repair mechanisms that protect cells. However, other factors, such as lifestyle, environment, occupation, diet and other environmental conditions may also enhance the risk of cancer in the general population. Current evidence has led to several theories on the causes of cancer, which have become major trends for understanding cancer causality and causation.
Binimetinib induced very few adverse events in the Phase 3 trial. No clinical meaningful differences between binmetinib and placebo were observed, in both terms of patient quality of life and safety in adults. In this trial, the frequency of fatigue was not higher in the binmetinib cohorts relative to placebo.
Binimetinib inhibits several cell lines of the BT family of cancer cells in vitro and is well tolerated and presents no significant risk of toxicity in vitro or in vivo in healthy monkeys or primates. binimetinib exhibits both in vitro and in vivo potency as a bcr-abl inhibitor. This observation is consistent with the in vivo efficacy and lack of toxicity noted in clinical phase 1 and 2 evaluations, and suggests a clinical role for binimetinib as a therapeutic option for patients with Philadelphia-positive chronic myeloid leukaemia and possibly other BT-positive B-cell chronic lymphoproliferative disorders.