Trametinib for Advanced Cancer

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Herbal supplements, Antiretrovirals

Disqualifiers: Interstitial lung disease, Brain metastases, Cardiovascular risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of trametinib in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) with or without liver (hepatic) dysfunction. Trametinib may stop the growth of tumor cells by blocking proteins needed for cell growth. When these proteins are blocked, the growth of cancer cells may be stopped and the cancer cells will then die. Hepatic dysfunction is frequently found in patients with advanced cancer and usually prevents patients from receiving standard treatments or from participating in clinical trials. Patients may also need dose adjustments or absorb drugs differently. Trametinib may be a better treatment for patients with advanced cancers and hepatic dysfunction.

Research Team

Lillian Siu, MD

Principal Investigator

University Health Network Princess Margaret Cancer Center LAO

Eligibility Criteria

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

I can take pills and don't have major stomach or bowel issues affecting drug absorption.

Platelets >= 75 x 10^9/L

PT =< 1.5 x institutional ULN

Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

I haven't taken any experimental drugs in the last 28 days.

I am not taking any medications that are not allowed in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Trametinib

Trial Overview The trial is testing Trametinib's effectiveness and safe dosage in advanced cancer patients with varying levels of liver function. The drug aims to block proteins essential for cancer cell growth which may stop the spread of the disease especially in those typically excluded from trials due to hepatic dysfunction.

Participant Groups

Group I: Treatment (trametinib) Experimental Treatment 1 Intervention

Patients receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Trametinib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Mekinist for:

• Melanoma
• Non-small cell lung cancer

Approved in United States as Mekinist for:

• Melanoma
• Non-small cell lung cancer
• Thyroid cancer

Approved in Canada as Mekinist for:

• Melanoma
• Non-small cell lung cancer

Approved in Japan as Mekinist for:

• Melanoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+