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DAY101 for Brain Tumor (FIREFLY-1 Trial)
FIREFLY-1 Trial Summary
This trial is studying a BRAF inhibitor as a possible treatment for pediatric, adolescent, and young adult patients with cancer.
FIREFLY-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFIREFLY-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FIREFLY-1 Trial Design
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Who is running the clinical trial?
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- My cancer is advanced or has spread, and tests show a RAF fusion.I am between 6 months and 25 years old.There may be additional criteria for participation in the study as specified in the protocol.My low-grade glioma has returned or worsened with a known BRAF mutation.My low-grade glioma has a confirmed BRAF gene mutation.I've had treatment for my condition and my scans show it's getting worse.I feel my cancer is getting worse even though scans don't show it.I have been diagnosed with or suspected to have neurofibromatosis type 1.I have at least one tumor that can be measured by specific medical criteria.My tumor has other known gene changes that help it grow.
- Group 1: Arm #1
- Group 2: Arm #3
- Group 3: Arm #2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the main purposes of this clinical experiment?
"According to the details reported by Day One Biopharmaceuticals, Inc., the primary outcome which will be tracked over a span of 48 months is Arm 3: Overall response rate (ORR) as evaluated using RECIST v1.1 criteria and reviewed independently by an IRC. Secondary outcomes include Arm 1: Visual acuity compared with baseline measured via Teller Acuity Cards® II; ORR assessed by Investigator based on RANO or RECIST criteria; and Arm 3: Time to response following DAY101 treatment commencement monitored through patient's best overall confirmed responses of CR or PR per RECIST v1.1 standards either from"
Are there numerous locations in Canada that are conducting this medical research?
"21 medical centres across the USA, Canada and beyond are currently involved in this trial. Residents should select the closest clinic to them if they wish to join as it will reduce necessary travel."
Who meets the criteria necessary to be approved for participation in this trial?
"This medical trial requires 140 individuals between the ages of 6 Months and 25 with glioma. To be admitted, applicants must fulfill a series of conditions such as having at least one lesion that meets RANO or RECIST v1.1 criteria (depending on arm), evidence of an activating BRAF alteration in arms 1 & 2, confirmation of LGG pathology coupled with molecular diagnosis for activating RAF fusion in arm 3, exposure to systemic therapy before enrollment along with evident radiographic progression."
How many participants are being recruited for this research initiative?
"Yes, the records hosted on clinicaltrials.gov indicate that recruitment is still open for this research project. Launched on March 17th 2021 and most recently modified on September 29 2022, 140 subjects have to be recruited from 21 distinct sites."
Are any opportunities available for patients to participate in this experiment?
"Clinicaltrials.gov confirms that this medical trial is currently recruiting patients, with its inception on March 17th 2021 and last update occurring September 29th 2022."
To what extent does DAY101 pose a risk to patients?
"Our team at Power gave DAY101 a score of 2 on their safety scale because there is evidence to support its security, but no proof that it can be effectively applied as treatment."
Does this research include participants younger than 45 years old?
"This research initiative is seeking participants aged between 6 months and 25 years."
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