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Kinase Inhibitor
Ibrutinib for Refractory Melanoma
Phase 2
Waitlist Available
Led By Stergios J Moschos
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Creatinine clearance estimated glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2 (Cockcroft-Gault)
Must not have
Prior exposure to ibrutinib or other ITK inhibitors
Patients with melanoma of mucosal or ocular primary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying whether ibrutinib can help treat patients with stage IV melanoma that has not responded to previous treatment.
Who is the study for?
This trial is for adults with stage IV cutaneous melanoma that hasn't improved after treatment. They must have measurable disease, normal organ function, and a life expectancy over 3 months. Participants need to be able to swallow pills, agree to use contraception if applicable, and provide tissue samples if needed. Excluded are those with certain allergies, uncontrolled illnesses, recent other cancer treatments or high-dose steroids.
What is being tested?
The trial tests Ibrutinib's effectiveness in treating advanced skin melanoma resistant to prior therapies by inhibiting enzymes that promote tumor cell growth. It includes laboratory biomarker analysis and pharmacological studies to understand how the drug interacts with the body.
What are the potential side effects?
Ibrutinib may cause side effects like diarrhea, muscle pain, rash or bruising; bleeding problems; infections; fatigue; irregular heartbeat; and hypertension. Side effects can vary from mild to severe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My kidney function, measured by creatinine clearance, is adequate.
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I have a tumor that can be measured and is at least 1 cm in size.
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I can swallow pills.
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My condition is at stage IV.
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I will stop taking Ibrutinib 3-7 days before and after surgery, based on bleeding risk.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with ibrutinib or similar medications before.
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My melanoma originated in a mucous membrane or my eye.
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I need regular blood transfusions due to low platelet counts.
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I haven't had chemotherapy, immunotherapy, or radiotherapy in the specified time before starting this trial.
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I am not currently on any other cancer treatments.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I have not had worsening anemia or low platelets due to autoimmune conditions in the last 4 weeks.
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I do not have serious heart problems or a recent heart attack.
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I cannot swallow pills or have a condition that affects my gut's ability to absorb nutrients.
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My liver function is not normal, as measured by the Child-Pugh score.
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I haven't taken strong CYP3A inhibitors in the last 7 days.
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I am not pregnant or breastfeeding.
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I have not had a stroke or brain bleed in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Subjects With Antitumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria 1.1
Secondary study objectives
Overall Survival
Progression Free Survival
Other study objectives
Change in Th1, Th2, and Various Immune Regulatory Cell Populations in Peripheral Blood Mononuclear Cells and Assessed by Flow Cytometry
Expression Levels of ITK and Putative Targets of Ibrutinib (e.g. Tec, ErbB4, Hck, Yes, BTK)
Pharmacokinetic Analysis on Ibrutinib Concentrations in Plasma Using WinNonlin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment4 Interventions
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~2060
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,920 Previous Clinical Trials
41,016,916 Total Patients Enrolled
Stergios J MoschosPrincipal InvestigatorDuke University - Duke Cancer Institute LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your AST and ALT levels in your blood are not too high. If you have cancer that has spread to your liver, the levels can be a little higher but still within a certain limit.My melanoma diagnosis was confirmed by tissue examination.My side effects from previous cancer treatments have mostly gone away.My melanoma originated in a mucous membrane or my eye.You have had serious allergic reactions to drugs similar to ibrutinib in the past, with symptoms like difficulty breathing, lip swelling, itching, or rash.I need regular blood transfusions due to low platelet counts.You have an active hepatitis B or C infection. If you are hepatitis B core antibody positive but antigen negative, you need a negative polymerase chain reaction (PCR) test before joining the study. If you are hepatitis B antigen or PCR positive, you cannot participate.Women who can become pregnant need to have a negative pregnancy test within 7 days before starting treatment with ibrutinib.I haven't had chemotherapy, immunotherapy, or radiotherapy in the specified time before starting this trial.I am not currently on any other cancer treatments.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am HIV-positive but on antiretroviral therapy with a normal CD4+ count.I do not have serious heart problems or a recent heart attack.I haven't taken warfarin or similar blood thinners in the last 28 days and don't have a bleeding disorder.My liver function is not normal, as measured by the Child-Pugh score.I haven't taken strong CYP3A inhibitors in the last 7 days.I have a tumor that can be measured and is at least 1 cm in size.I can swallow pills.Your hemoglobin level is at least 9.0 grams per deciliter.Your platelet count is higher than 100,000 per microliter.I haven't taken high doses of corticosteroids daily for the last 28 days.I have been treated with ibrutinib or similar medications before.I have not had worsening anemia or low platelets due to autoimmune conditions in the last 4 weeks.I had cancer before, but it's either been treated, is a non-threatening type, or I've been cancer-free for 2+ years.I cannot swallow pills or have a condition that affects my gut's ability to absorb nutrients.I've had radiation before, but my current cancer spots haven't been treated with it.I can take care of myself but might not be able to do heavy physical work.My bilirubin levels are normal or slightly elevated, unless due to Gilbert's syndrome or liver disease.My kidney function, measured by creatinine clearance, is adequate.My cancer did not respond to treatment with PD1/PD-L1 inhibitors after at least two doses.I agree to use effective birth control during and for 90 days after the study.I have an autoimmune disease but take 20 mg or less of corticosteroids daily.I am willing to undergo a biopsy for my metastatic melanoma if needed.I had severe side effects from BRAF or MEK inhibitors that didn't improve even after changing medications.My brain cancer is under control, and I'm on a low or decreasing dose of steroids.I am not pregnant or breastfeeding.I have not had a stroke or brain bleed in the last 6 months.You are expected to live for more than 3 months.Your absolute neutrophil count is higher than 1,500 per microliter.My condition is at stage IV.I will stop taking Ibrutinib 3-7 days before and after surgery, based on bleeding risk.My cancer has not responded to specific treatments for the BRAFV600 mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ibrutinib)
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.
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