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Kinase Inhibitor
Trametinib for Hormone-Resistant Prostate Cancer
Phase 2
Waitlist Available
Led By Matthew Rettig
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic tumor that has been biopsied
Histologically confirmed prostate cancer (not exclusive of adenocarcinoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
Study Summary
This trial is studying how well trametinib works in treating patients with hormone-resistant prostate cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Trametinib may cause side effects such as skin rash, diarrhea, fatigue, nausea, swelling in the face or limbs (peripheral edema), high blood pressure (hypertension), shortness of breath (dyspnea), abnormal bleeding or bruising due to low platelet count (thrombocytopenia), vision changes like blurred vision or reduced visual acuity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My metastatic tumor has been biopsied.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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My blood clotting time is within the safe range.
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I am on therapy to keep my testosterone levels below 50 ng/dL.
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I am able to care for myself and perform daily activities.
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My prostate cancer has worsened despite treatment with abiraterone and/or enzalutamide.
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I am willing to have a biopsy if my cancer gets worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PSA response rate
Response rate assessed by RECIST criteria
Secondary outcome measures
Change in markers of cell proliferation (Ki67) and apoptosis (p27), assessed by immunohistochemistry
Change in trametinib target engagement of MEK1/2 defined by the presence of p-ERK, assessed by immunohistochemistry
Durability of PSA response as measured by time to PSA progression as defined by PCWG2 guidelines
+8 moreOther outcome measures
ctDNA genomic aberrations, assessed by exome sequencing
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib)Experimental Treatment3 Interventions
Patients receive trametinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550
Find a Location
Who is running the clinical trial?
NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,256 Total Patients Enrolled
22 Trials studying Prostate Cancer
4,934 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,766 Total Patients Enrolled
28 Trials studying Prostate Cancer
1,930 Patients Enrolled for Prostate Cancer
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,036 Total Patients Enrolled
39 Trials studying Prostate Cancer
4,000 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any cancer other than non-melanoma skin cancer in the last 5 years.I have had interstitial lung disease or pneumonitis.I haven't taken any prostate cancer or PSA affecting meds, or high-dose steroids recently.I have brain metastasis or spinal issues related to my cancer.I have a stomach or bowel condition that affects how my body absorbs food.My metastatic tumor has been biopsied.My prostate cancer diagnosis was confirmed through a tissue examination.My heart's pumping ability is below 45%.I have had a heart attack, unstable angina, or a procedure to open my heart's arteries within the last 6 months.I have not had unstable chest pain in the last 3 months.My blood clotting time is within the safe range.I am not taking medications that affect hormone levels.I am on therapy to keep my testosterone levels below 50 ng/dL.My kidney function is normal or meets specific criteria if not.I am able to care for myself and perform daily activities.I have had or am at risk for a specific eye condition (RPED).I have severe heart failure.I haven't had major surgery or intense cancer treatment in the last 30 days.I do not have any health conditions that would stop me from following the study's requirements.I have previously used trametinib or a similar drug.I have a history of serious heart rhythm problems.My prostate cancer has worsened despite treatment with abiraterone and/or enzalutamide.I have had retinal vein occlusion or am at risk for it.I am willing to have a biopsy if my cancer gets worse.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (trametinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent have there been investigations regarding Trametinib's efficacy?
"Presently, 92 separate Trametinib trials are in progress with 6 of them at the Phase 3 stage. While Philadelphia, Pennsylvania has several studies dedicated to this medication, there are 5794 total locations running clinical trials involving Trametinib."
Answered by AI
What is the cap on participant numbers for this clinical trial?
"This medical trial is no longer recruiting participants, having been initially posted on the 30th of January 2018 and last updated on the 21st of July 2022. For individuals searching for other studies, there are currently 3655 trials actively enrolling patients with malignant neoplasms as well 92 clinical trials administering Trametinib that are still admitting candidates."
Answered by AI
How profoundly hazardous is Trametinib for individuals?
"Trametinib's safety has been observed in Phase 2 trials, thus it was assigned a score of 2. Unfortunately, no efficacy data is currently available to support its use."
Answered by AI
Are there any available slots to join this research endeavor?
"Unfortunately, clinicaltrials.gov states that this trial is not actively recruiting participants any longer. Despite the initial posting on January 30th 2018 and last update being July 21st 2022, there are still over 3700 other trials searching for volunteers at present."
Answered by AI
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