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Kinase Inhibitor
Turalio for Leukemia
Phase 1
Recruiting
Led By Rosandra N Kaplan, M.D.
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
Patients with NF1 and with malignant peripheral nerve sheath tumor (MPNST) are eligible
Patients must be aged between 3 and 35 years with a body surface area (BSA) of at least 0.55 m^2
Must not have
Ongoing treatment with any other cancer therapy or investigational agent, except for IT chemotherapy for leukemia when indicated
Individuals who require therapy with warfarin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before c1 and then c1d7 and then at each restaging evaluation
Awards & highlights
Summary
This trial is testing a drug called PLX3397 to see if it can help treat certain types of cancer. Eligible participants will take the drug once daily for a 28-day cycle, and will have various tests and procedures throughout the study.
Who is the study for?
This trial is for young people aged 3-35 with certain types of cancer that haven't responded to other treatments. They should have solid tumors or specific leukemias (AML, ALL), be able to swallow capsules, and have a performance status indicating they can do daily activities. Patients must not have active infections or be pregnant, and need adequate blood counts and organ function.Check my eligibility
What is being tested?
Researchers are testing Turalio(R) (Pexidartinib) in children and young adults with refractory cancers including leukemia and solid tumors like neurofibromas associated with NF1. The goal is to find the highest safe dose of Turalio(R), understand its side effects, and see if it helps treat these cancers.See study design
What are the potential side effects?
While the exact side effects aren't listed here, participants will closely monitor their symptoms in a diary. Side effects could include typical reactions from cancer drugs such as nausea, fatigue, liver issues, changes in blood counts leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have NF1 and a cancerous tumor in my nerve sheath.
Select...
I am between 3 and 35 years old with a body size of at least 0.55 m^2.
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I can swallow pills.
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I am mostly self-sufficient and can do most activities.
Select...
My condition did not improve after standard treatments.
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I can understand and sign the consent form myself or have someone legally authorized to do so.
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My cancer has come back or didn't respond to treatment, or I couldn't tolerate the treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not on any cancer treatment except for specific leukemia therapy.
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I need to take warfarin for my condition.
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I do not have active hepatitis or HIV.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I have an infection that hasn't been treated yet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first cycle
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first cycle
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: determine a phase II dose of TURALIO(R)
Secondary outcome measures
Correlative analysis of immune endpoints with response
Safety
To characterize the pharmacokinetic profile
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Phase IExperimental Treatment1 Intervention
take oral drug daily for a 28 day cycle
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,347 Total Patients Enrolled
Rosandra N Kaplan, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
6,226 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have NF1 and a cancerous tumor in my nerve sheath.I am between 3 and 35 years old with a body size of at least 0.55 m^2.I can swallow pills.I am mostly self-sufficient and can do most activities.I am not on any cancer treatment except for specific leukemia therapy.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer has come back or didn't respond to treatment, or I couldn't tolerate the treatment.I am on steroids and meet the specific requirements for their use.I have stopped all previous cancer treatments by the required time before joining.My blood, liver, and kidney functions are all within normal ranges.I do not have active hepatitis or HIV.I can understand and sign the consent form myself or have someone legally authorized to do so.I need to take warfarin for my condition.My condition did not improve after standard treatments.I haven't taken drugs that strongly affect CYP3A4 enzyme recently.I have recovered from side effects of previous cancer treatments.I have an infection that hasn't been treated yet.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I
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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