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Kinase Inhibitor

DAY101 for Brain Tumor

Phase 1
Waitlist Available
Research Sponsored by Karen D. Wright, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient who has failed standard therapy
Patients must be >1 year and <25 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1 1-4 hours post dose; cycle 1 day 3-6 random level; cycle 2 day 1 pre-dose; cycle 3 day 1 random level; end of therapy or at time of toxicity requiring patient be taken off study or dose held; time of surgery if applicable)
Awards & highlights

Study Summary

This trial is studying how well Tovorafenib/DAY101 (formerly TAK-580, MLN2480) works in treating patients with a low-grade glioma that has not responded to other treatments.

Who is the study for?
This trial is for pediatric patients aged 1-25 with recurrent or progressive brain tumors (gliomas) not responding to other treatments, and whose tumors are linked to a specific cellular pathway (RAS/RAF/MEK/ERK). Participants must have adequate organ function, be able to swallow pills, and agree to effective contraception. Excluded are those with certain genetic conditions (NF1), recent major surgery, uncontrolled heart issues, active infections, or inadequate blood counts.Check my eligibility
What is being tested?
The study tests Tovorafenib/DAY101 as a treatment for low-grade glioma that's come back or worsened despite previous therapies. It focuses on children and young adults who've had no success with standard care options. The drug targets a specific growth-related pathway in cancer cells.See study design
What are the potential side effects?
While the trial doesn't list specific side effects of DAY101/Tovorafenib, similar drugs often cause fatigue, skin rash, digestive issues like nausea or diarrhea, vision changes due to retinal problems and liver enzyme alterations which can indicate liver stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My previous treatments for my condition did not work.
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I am between 1 and 25 years old.
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My cancer has a mutation in the RAS/RAF/MEK/ERK pathway.
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My child's cancer is worsening and involves a specific cancer pathway but not NF1.
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I can do most of my daily activities on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 1-4 hours post dose; cycle 1 day 3-6 random level; cycle 2 day 1 pre-dose; cycle 3 day 1 random level; end of therapy or at time of toxicity requiring patient be taken off study or dose held; time of surgery if applicable)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 1-4 hours post dose; cycle 1 day 3-6 random level; cycle 2 day 1 pre-dose; cycle 3 day 1 random level; end of therapy or at time of toxicity requiring patient be taken off study or dose held; time of surgery if applicable) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT)
Secondary outcome measures
Best Overall Response
Blood samples for DAY101 concentration measurements (i.e. pharmacokinetic measures)
Number of participants with adverse events
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: DAY101 (formerly TAK-580, MLN2480) BSA > 1.5m^2Experimental Treatment1 Intervention
Phase I Part B BSA > 1.5m^2 Patients (< 25 years) with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) or solid tumors) associated with activation of the RAS/RAF/MEK/ERK pathway will be eligible with the exception of patients with NF1 Study treatment cycle lasts 28 days, oral, once a week
Group II: DAY101 (formerly TAK-580, MLN2480) BSA </= 1.5m^2Experimental Treatment1 Intervention
Phase I Part B BSA </= 1.5m^2 Patients (< 25 years) with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) or solid tumors) associated with activation of the RAS/RAF/MEK/ERK pathway will be eligible with the exception of patients with NF1 Study treatment cycle lasts 28 days, oral, once a week

Find a Location

Who is running the clinical trial?

Karen D. Wright, MDLead Sponsor
PLGA Fund at Pediatric Brain Tumor FoundationUNKNOWN
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
693 Total Patients Enrolled

Media Library

Tovorafenib/DAY101 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03429803 — Phase 1
Low Grade Glioma Research Study Groups: DAY101 (formerly TAK-580, MLN2480) BSA </= 1.5m^2, DAY101 (formerly TAK-580, MLN2480) BSA > 1.5m^2
Low Grade Glioma Clinical Trial 2023: Tovorafenib/DAY101 Highlights & Side Effects. Trial Name: NCT03429803 — Phase 1
Tovorafenib/DAY101 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03429803 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other experimental treatments have been initiated utilizing DAY101?

"The initial research on DAY101 was conducted in 2018 at Johns Hopkins University. Subsequently, two trials have been fulfilled and presently there is one active trial taking place primarily around Boston, Massachusetts."

Answered by AI

What criteria must I fulfill to be eligible for this clinical trial?

"This trial requires 44 participants suffering from glioma, ranging between 1-25 years of age. Most notably, patients must have unsuccessfully attempted standard treatment such as surgery for resectable low grade glioma. Furthermore, even if the patient is unable to walk due to paralysis they will be considered ambulatory for performance assessment purposes providing that are up in a wheelchair. In addition, those under 16 years old should possess a Lansky score of over 50 and there needs to exist at least one lesion which can be quantified using two measurements."

Answered by AI

How many people is the research team recruiting for this trial?

"At present, this clinical trial has ceased to recruit new candidates. Initially posted on February 27th 2018 and recently edited June 8th 2022, the study is no longer accepting participants. However, there are currently 355 other medical trials actively enrolling those suffering from glioma as well as 1 experiment for DAY101 in desperate need of human subjects."

Answered by AI

Is this research experiment unprecedented in its area?

"DAY101 has been under medical investigation since 2018, with the inaugural study sponsored by Day One Biopharmaceuticals. Following a successful trial involving 44 participants, DAY101 successfully completed Phase 1 drug approval stage. Currently there is only one active research project for DAY101 being led by Day One Biopharmaceuticals."

Answered by AI

Is this trial being conducted in various parts of Canada?

"The 15 trial sites recruiting participants include Massacusetts General Hospital in Boston, Dana-Farber Cancer Institite in Minneapolis, and Children's Minnesota in Seattle. Other locations are also accepting enrollees for this study."

Answered by AI

Is it possible for individuals over the age of 79 to partake in this experiment?

"The requirements for this medical trial specify that eligible participants should be between 1 Year and 25 years old. In total, there are 135 trials open to minors and another 237 studies available for people over 65."

Answered by AI

What issues might arise from the utilization of DAY101?

"The safety of DAY101, which is still in its first stage of clinical trials, has been assessed as a 1 due to the limited data available regarding efficacy and harms."

Answered by AI

Are there vacancies available for individuals who would like to join this trial?

"At this time, no more participants are being accepted for this trial. Initially published on February 27th 2018 and last edited June 8th 2022, there are now 355 trials available to those looking for glioma studies and 1 study that is admitting patients to DAY101."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
DAY101 In Gliomas and Other Tumors
Karen D. Wright, MD 2018. "DAY101 In Gliomas and Other Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03429803.
~4 spots leftby Dec 2024
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