Dosage & Regimen for MEK Inhibitor: Cancer Clinical Trial

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Table of Contents

Type of Clinical Trial
Purpose of Study
Criteria for Inclusion in the Trial
Exclusion Criteria
Side Effects or Adverse Reactions
Pros and Cons of the Study
Work Cited

Type of Clinical Trial

The study is a treatment trial aimed at designing the correct dose of GSK1120212.

Purpose of Study

The trial is aimed at determining the dosage and regimen for MEK inhibitor that should be mixed with everolimus in order to be administered to a patient with solid tumors. Further trial is to be done for patients with metastatic pancreatic cancer using the same regimen and inhibitor. In addition, people with mutant non-small lung cancer are also to be incorporated in the trial. The main purpose is treatment of cancer by determining the correct dosage.

Who Are the Sponsors?

The trial is sponsored by GlaxoSmithKline.

What Phase is the Clinical Trial Presently in?

The project is in phase IB II with the aim being investigation of safety of MEK inhibitor. It was started in August 6, 2009 and it is expected to be complete by September 2011.

What type of study was used?

This is a non-randomized study method.

Who are the participants?

The participants are divided into three groups. The first group comprises of about thirty people with solid tumor. The second group involves about twenty people with pancreatic cancer while the last is a group of about forty people who have lung cancer. All the participants are to be given a dose of GSK1120212 mixed with everolimus. The quantity of drug administered is to be escalated until a recommended dose is identified (United States National Institute of Health 1).

How Are They Solicited?

The participants were recruited on pure voluntary basis and they were expected to continue with the study up to the final stage. However, any person is free to withdraw from the trial anytime.

Criteria for Inclusion in the Trial

For a participant to be included in the trial, he or she should satisfy the following criteria:

He/she should be above eighteen years of age and capable of swallowing oral medication.
Should be able to consent by signing a form with requirements and limitations for the trial.
One should meet the satisfactory organ system function, meaning all the body organs should be functioning well.
Female participants should not have a child bearing potential and if they have, they should be ready to use contraceptives described by the protocol.
One should meet the tumor criteria enlisted here.
Male participants should agree to use contraceptives described in the protocol.
The participants’ fasting glucose should be less than 126mg/dL.

Exclusion Criteria

People with the following condition may be excluded from the study:

Malignancies associated with HIV or organ transplant
Brain tumors
Currently using anticoagulants, especially if it is within seven days before the GSK1120212 dose is administered
Allergic to any component of the drug
History of treatment with mTOR inhibitor
Gastrointestinal infections that may interfere with the absorption of the drug
Glaucoma that has been diagnosed one month before the start of taking the drug

Age of Participants

All the participants, both male and female, should have attained at least eighteen years to be eligible for the trial study.

Side Effects or Adverse Reactions

Some side effects were recorded at the dose of 2mg/day. Nine subjects experienced diarrhea and seven subjects had rushes. Other reactions included fatigue and cerebrovascular. The most serious effect was retinopathy that caused visual changes to one participant but it reversed after the withdrawal of medication (United States National Institute of Health).

Pros and Cons of the Study

Involving oneself in this trial could have the following pros.

Participants receive free careful checkups from highly qualified medical practitioners
In case of a breakthrough the participant will be the first beneficiary
Positive outcomes may help other people in future

The cons of participating in the trial are:

Unexpected side effects may arise and develop a serious health problem to the participant
A lot of time may be consumed visiting the doctors for the trial than if they were taking the regular medication
Health insurance may be unable to cover all the expenses for a patient engaged in the trials

Work Cited

“United States National Institute of Health.” ClinicalTrials.gov. ClinicalTrials.gov., n.d. Web.

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