Trametinib for Hormone-Resistant Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Matthew Rettig

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies how well trametinib works in patients with advanced prostate cancer that has not responded to typical hormone treatments. Trametinib aims to stop cancer cells from growing by blocking essential enzymes.

Eligibility Criteria

This trial is for men with advanced prostate cancer that has spread and no longer responds to hormone therapy. Participants must have low testosterone levels maintained by ongoing therapy, adequate heart function, good blood counts, normal liver and kidney function, and be able to consent. They should not have other serious health issues or a history of certain heart diseases.

Inclusion Criteria

Left ventricular ejection fraction (LVEF) >= 45% as measured by echocardiogram during screening evaluation

Aspartate aminotransferase (AST) within the reference range during screening evaluation

My metastatic tumor has been biopsied.

Exclusion Criteria

I have not had any cancer other than non-melanoma skin cancer in the last 5 years.

Patients with intra-cardiac defibrillators or permanent pacemakers

I have had interstitial lung disease or pneumonitis.

Participant Groups

The study is testing Trametinib's effectiveness in stopping tumor growth by inhibiting specific enzymes needed for cell growth in patients with metastatic hormone-resistant prostate cancer. It includes laboratory biomarker analysis and quality-of-life assessments.

Group I: Treatment (trametinib) Experimental Treatment 3 Interventions

Patients receive trametinib PO QD. Treatment continues 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCLA / Jonsson Comprehensive Cancer Center Los Angeles, CA

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center Lead Sponsor

Novartis Industry Sponsor

Prostate Cancer Foundation Collaborator

Stand Up To Cancer Collaborator

References