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DAY101 vs. Chemotherapy for Pediatric Brain Cancer
Phase 3
Recruiting
Research Sponsored by Day One Biopharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
Study Summary
This trial compares a new therapy to standard chemo for kids with LGG and a certain gene alteration.
Who is the study for?
This trial is for children and young adults under 25 with a type of brain tumor called low-grade glioma that has a specific genetic change (RAF alteration). They should have a measurable tumor but can't have had any previous cancer treatments like chemo or radiation, and shouldn't have certain other medical conditions or additional genetic changes in their tumors.Check my eligibility
What is being tested?
The study compares DAY101, which is an experimental drug, to the standard chemotherapy drugs usually given for this condition. It's designed to see which treatment works better as the first line of attack against these brain tumors in kids and young adults.See study design
What are the potential side effects?
While specific side effects are not listed here, DAY101 and standard chemotherapies can cause various reactions. These might include nausea, fatigue, hair loss, increased risk of infections due to lowered immunity, and possible damage to organs over time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare the objective response rate (ORR) assessed per RANO criteria by independent review committee (IRC) of DAY101 monotherapy versus standard of care (SoC) chemotherapy
Secondary outcome measures
Compare changes in neurological function between DAY101 versus SoC
Compare changes in visual function outcomes of DAY101 monotherapy versus SoC chemotherapy in patients with optic pathway glioma (OPG)
Pharmacotherapy
+9 moreSide effects data
From 2013 Phase 3 trial • 275 Patients • NCT0049910977%
Fatigue (asthenia, lethargy, malaise)
62%
Nausea
58%
Hair loss/alopecia (scalp or body)
46%
Diarrhea
42%
Vomiting
27%
Low Hemoglobin
27%
Constipation
27%
Neuropathy: sensory
27%
Taste alteration (dysgeusia)
23%
Rash/desquamation
23%
Dyspnea (shortness of breath)
23%
Anorexia
23%
Pain - Head/headache
19%
Cough
19%
Febrile neutropenia
15%
Pain - Back
15%
Nail changes
15%
Dizziness
15%
Edema: limb
15%
Musculoskeletal/Soft Tissue - Other
15%
Pain - Extremity-limb
12%
Fever (in the absence of neutropenia)
12%
Pain - Chest/thorax NOS
12%
Insomnia
12%
Watery eye (epiphora, tearing)
12%
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
8%
Potassium, serum-low (hypokalemia)
8%
Pain - Chest wall
8%
Sweating (diaphoresis)
8%
Pain - Joint
8%
Gastrointestinal - Other
8%
Pain - Other
8%
Cognitive disturbance
8%
Constitutional Symptoms - Other
8%
Febrile neutropenia: fever - unknown origin W/O clinically or microbiologically documented infection
8%
Pain - Abdomen NOS
8%
Low Neutrophils/granulocytes (ANC/AGC)
8%
Low Platelets
8%
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
8%
Rigors/chills
8%
Hemorrhage, pulmonary/upper respiratory - Nose
4%
Neuropathy: motor
4%
Obstruction, GU - Ureter
4%
Glucose, serum-low (hypoglycemia)
4%
Syncope (fainting)
4%
Dehydration
4%
Gastritis (including bile reflux gastritis)
4%
Vision-blurred vision
4%
Mood alteration - Depression
4%
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils/Skin/cellulitis
4%
Mood alteration - Anxiety
4%
Fracture
4%
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body
4%
Infection with unknown ANC - Wound
4%
Pain - Bone
4%
Dermatology/Skin - Other
4%
Dysphagia (difficulty swallowing)
4%
Dry Skin
4%
Weight loss
4%
Blood/Bone Marrow - Other
4%
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils/Lung/pneumonia
4%
Metabolic/Laboratory - Other
4%
Infection with unknown ANC - Lung (pneumonia)
4%
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
4%
Death not associated with CTCAE term - Death NOS
4%
Thrombotic microangiopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: E2
Control: C
Experimental: E4
Experimental: E3
Experimental: E1
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm #1Experimental Treatment1 Intervention
DAY101
Group II: Arm #2Active Control1 Intervention
Investigator's choice of one of the following current standard of care for pediatric patients with low-grade gliomas:
Children's Oncology Group - Vincristine/Carboplatin (COG-V/C)
International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C)
Vinblastine (VBL)
Find a Location
Who is running the clinical trial?
SIOPe Brain Tumor Group LOGGIC ConsortiumUNKNOWN
Day One Biopharmaceuticals, Inc.Lead Sponsor
6 Previous Clinical Trials
490 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need treatment for my condition for the first time.My diagnosis is a type of brain tumor called glioma or glioneuronal.My tumor is identified as Schwannoma, SEGA, or DIPG.I am currently undergoing or have completed non-surgical cancer treatment.My tumor has other gene changes that make it grow.I have been diagnosed with neurofibromatosis Type 1 or 2.I am under 25 and have a low-grade glioma with a specific RAF gene change.
Research Study Groups:
This trial has the following groups:- Group 1: Arm #2
- Group 2: Arm #1
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What has been established regarding the safety of Arm #1 for human participants?
"Our assessment of Arm #1's safety is rated a 3 due to the substantial evidence from Phase 3 trials that affirm both efficacy and security."
Answered by AI
Is there still capacity for participants in this research experiment?
"According to information housed on clinicaltrials.gov, this trial is presently seeking participants with the initial post-date being February 1st 2023 and last edited date of February 3rd 2023."
Answered by AI
What is the size of the cohort participating in this clinical trial?
"Confirmed. Clinicaltrials.gov has the details of this ongoing medical trial, which was initially posted on February 1st 2023, and recently updated on March 2nd 2023. A total of 400 patients are sought at a single medical centre for enrollment in this study."
Answered by AI
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