Binimetinib for Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Princess Margaret Cancer Centre, Toronto, Canada
Cancer+1 More
Binimetinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a drug called binimetinib can help treat cancer.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Tumors, Solid

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

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.

2.5 years
Change in circulating tumor DNA (ctDNA) profiles measured by serial analysis of ctDNA profiles at baseline, mid-cycle 1, with each subsequent cycle, and at progression, validated by comparison to molecular profiles of corresponding fresh tumor biopsies
Disease Control Rate defined in accordance with RECIST v1.1, as the percentage of patients who achieve a complete response, partial response or stable disease after 24 weeks of treatment.
Disease progression defined as per RECIST v1.1 and monitored throughout the study period. Progression Free Survival defined as time from study registration to disease progression or death from any cause.
Number of fresh tumor biopsies collected, frozen, and stored for subsequent development of patient derived xenografts.
Number of identified molecular mechanisms of acquired resistance to binimetinib and encorafenib in tumors with non-V600E BRAF mutations, measured by analysis of molecular profiles and validated with PDX models in vitro and in vivo.
Number of participants with toxicities as per NCI CTCAE v5.0.
Objective response rate defined as per RECIST v1.1.
Overall survival measured as the length of time from the first day of treatment to the day of death. Median OS will be reported.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Binimetinib + Encorafenib

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.

Binimetinib + EncorafenibBinimetinib and encorafenib are administered orally on a twice daily or once daily schedule, respectively in 28-day cycles. Treatment will continue until it is discontinued due to unacceptable toxicity, clinical or radiological disease progression as per RECIST 1.1, investigator decision, and/or withdrawal of consent.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
FDA approved
Encorafenib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2.5 years for reporting.

Closest Location

Princess Margaret Cancer Centre - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient must be diagnosed with a histologically or cytologically-documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the patient and treating physician.
Measurable disease by RECIST v1.1 criteria.
All patients enrolled must be willing and able to provide at least 1 archival and/or fresh tumor biopsy at baseline for histopathological and molecular evaluation during the screening period with binimetinib and encorafenib. Additional matched pre-treatment and on-treatment fresh tumor biopsies are mandatory for 10 patients enrolled in stage 2. Any patient with insufficient or inadequate archival tissue samples will be required to provide a fresh tumor biopsy. For all other patients, a fresh baseline biopsy is optional, but highly recommended. If a patient only has a single measurable lesion by RECIST v1.1, this lesion can be used for baseline biopsy if it is 2cm or greater.
Informed consent
Signed written and voluntary informed consent.
Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Age > 18 years, male or female.
Disease characteristics
Malignancy must express one of the following BRAF alterations: BRAF mutation affecting codon: 241, 257, 367, 462, 463, 464, 466, 467, 469, 485, 581, 586, 594, 595, 596, 597 598, 599, 601; V600 BRAF mutations: V600K (for any malignancy except melanoma), V600D, V600M, V600R; BRAF deletions ie. V600_K601delinsE or 1799_1801 del TGA; BRAF insertions ie. T599dup; BRAF fusions ie. KIAA1549:BRAF
Patient must be able to swallow pills

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for cancer?

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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.

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How many people get cancer a year in the United States?

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Approximately 4 million people a year are diagnosed with cancer in the USA, making it the second most common cause of mortality after heart disease, after non-fatal injuries.

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What causes cancer?

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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.

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What is cancer?

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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'.

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What are the signs of cancer?

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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.

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Can cancer be cured?

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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.

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Is binimetinib typically used in combination with any other treatments?

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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.

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What is the latest research for cancer?

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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.

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What are the common side effects of binimetinib?

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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.

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What is the primary cause of cancer?

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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.

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Is binimetinib safe for people?

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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.

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How does binimetinib work?

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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.

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