Trametinib for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of trametinib for people with advanced cancer, particularly those whose cancer resists usual treatments. Trametinib blocks certain proteins that aid cancer cell growth, potentially stopping or killing the cancer. The trial focuses on individuals with liver problems that often hinder standard treatments. People with advanced cancer unresponsive to other treatments and who have liver issues might be suitable for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this potentially groundbreaking therapy.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot use other anti-cancer therapies or herbal supplements during the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that trametinib is likely to be safe for humans?
Research has shown that trametinib, a drug under study for advanced cancer, has safety information from past studies. In earlier research with melanoma patients, trametinib was tested and found to have some side effects. A small number of people experienced a serious fever, known as pyrexia, with about 5% requiring hospital care. Other side effects included rash and high blood pressure, which were serious but not very common.
The FDA has already approved trametinib for treating certain types of cancer when used with other drugs. This approval suggests that trametinib is generally considered safe enough for use, though monitoring for side effects remains important.
Overall, while trametinib carries some risks, it has been tested in humans before and shows promise for treating advanced cancers.12345Why do researchers think this study treatment might be promising?
Trametinib is unique because it targets a specific pathway involved in cancer cell growth called the MEK pathway, which is different from many standard treatments that often focus on other parts of the cell cycle. This targeted approach can potentially lead to more precise attacks on cancer cells while sparing healthy ones, reducing side effects. Researchers are excited about trametinib because it offers a new way to tackle advanced cancers, especially for patients who may not respond well to traditional chemotherapy or radiation therapies.
What evidence suggests that trametinib might be an effective treatment for advanced cancer?
Research has shown that trametinib, the treatment under study in this trial, can slow the growth of certain cancers. In one study, patients taking trametinib lived an average of 4.9 months without their cancer worsening, compared to just 1.5 months for those not taking it. Additionally, after five years, many patients on trametinib lived longer. This suggests that trametinib, which blocks proteins necessary for cancer cell growth, may help manage advanced cancers, even in patients with liver problems where usual treatments might not work. While more research is needed, these findings offer promise for those considering participation in clinical trials with trametinib.678910
Who Is on the Research Team?
Lillian Siu, MD
Principal Investigator
University Health Network Princess Margaret Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for patients with advanced cancers that can't be cured or controlled, including those with liver dysfunction. It includes people who've failed previous treatments like BRAF inhibitors for melanoma and have solid tumors such as pancreatic cancer. Participants must be able to take oral medication, have a life expectancy over 3 months, and not have had recent other treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive trametinib orally once daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trametinib
Trametinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Melanoma
- Non-small cell lung cancer
- Melanoma
- Non-small cell lung cancer
- Thyroid cancer
- Melanoma
- Non-small cell lung cancer
- Melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor