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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

Must not have

Patients with specific eye conditions or skin reactions

Certain infections or conditions

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have certain eye or skin conditions.

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I have no current infections or serious health conditions.

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I have been diagnosed with Neurofibromatosis type 1 (NF1).

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I have heart problems that are not well-managed.

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I have a specific condition affecting my digestive system.

Timeline

Screening ~ 3 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicity (DLT)

Secondary study objectives

Best Overall Response

Blood samples for DAY101 concentration measurements (i.e. pharmacokinetic measures)

Number of participants with adverse events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met