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Trial Title:
Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Glioma
NCT ID:
NCT05760586
Condition:
Low-grade Glioma
Conditions: Official terms:
Glioma
Conditions: Keywords:
DAY101
Toverafenib
Glioma
BRAF Mutation
RAF Alteration
Type II BRAF Inhibitor
Neoplasms
Study type:
Expanded Access
Overall status:
Approved for marketing
Intervention:
Intervention type:
Drug
Intervention name:
Tovorafenib
Description:
Oral RAF inhibitor provided as an immediate-release tablet (100 mg) or powder for
reconstitution (25 mg/mL)
Other name:
DAY101
Summary:
The DAY101-EAP is a multicenter, open-label, expanded access treatment protocol designed
to provide access to tovorafenib (DAY101) for eligible patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for enrollment in the
EAP:
1. Patients must be aged 6 months to 25 years, inclusive, with a relapsed or refractory
low-grade glioma with a documented known or expected to be activating BRAF mutation
or RAF fusion, as identified through molecular assays as routinely performed at
CLIA-certified or other similarly certified laboratories.
2. Patients must have histopathologic diagnosis of glioma or glioneuronal tumor (Grade
1 or 2 according to WHO classification for CNS tumors at either original diagnosis
or relapse.
3. Patients must have received at least one line of prior systemic therapy and have
documented evidence of radiographic progression.
4. Previous chemotherapy and/or targeted/immunotherapy/monoclonal antibody therapy must
be completed at least 4 weeks or 5 half-lives (whichever is shorter) prior to the
initiation of therapy.
5. Chronic toxicities from prior anticancer therapy must be stable and at CTCAE Version
5.0 Grade ≤ 2.
6. Patients must have fully recovered from any prior surgery.
7. Patients must have adequate hematologic function, as defined by the following:
1. Absolute neutrophil count≥ 1000/mm3
2. Platelet count≥ 75.0 × 109/L
3. Hemoglobin≥ 10.0 g/dL (transfusions allowed up to 14 days prior to enrollment
per institutional guidelines)
8. Patients must have adequate hepatic and renal function, defined by the following:
1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) for age (If patient has
documented Gilbert's Disease, patient may be enrolled with Sponsor approval,
provided that bilirubin is < 2.0 × ULN)
2. Serum glutamic-pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≤ 3 ×
ULN
3. Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate transaminase (AST) ≤ 3
× ULN
4. Serum creatinine within normal limits, or estimated glomerular filtration rate
≥ 60 mL/min/1.73 m2 based on local institutional practice for determination
9. Thyroid function tests must be consistent with stable thyroid function.
10. Patients must be able to comply with treatment, laboratory monitoring, and required
clinic visits for the duration of EAP participation.
11. Male and female patients with reproductive potential must be willing to use birth
control methods per Appendix E of protocol.
12. Patients must be able to swallow tablets or liquid or administer through gastric
access via feeding tube(12Fr or greater)
13. Parent/guardian of child or adolescent patient must have the ability to understand,
agree to, and sign the EAP informed consent form (ICF) and applicable pediatric
assent form before initiation of any treatment-related procedures; patient must have
the ability to give assent, as applicable, at the time of parental/guardian consent.
Exclusion Criteria:
Patients meeting any of the following criteria are to be excluded from EAP participation:
1. Patient's tumor has an additional previously known or expected to be activating
molecular alteration(s) (e.g., histone mutation, IDH1/2 mutations, FGFR mutations or
fusions, MYBL alterations, neurofribromatosis type 1 (NF-1) somatic or germline
mutations).
2. Patient has known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via
genetic testing or current diagnostic criteria.
3. Patient has history of any major disease, other than the primary malignancy under
EAP, that might interfere with safe protocol participation.
4. Patient has major surgery within 14 days (2 weeks) prior to C1D1 (does not include
central venous access, cyst fenestration or cyst drainage, or ventriculoperitoneal
shunt placement or revision).
5. Patient has clinically significant active cardiovascular disease, or history of
myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months
prior to C1D1, ongoing cardiomyopathy, or current prolonged QT interval corrected
for heart rate by Fridericia's formula (QTcF) interval > 470 milliseconds based on
triplicate electrocardiogram (ECG) average.
6. Patient has an active systemic bacterial, viral, or fungal infection.
7. Patient has malabsorption requiring supplementation, or significant bowel or stomach
resection that would preclude adequate absorption of tovorafenib (DAY101).
8. Concomitant medications that are strong inhibitors or inducers of CYP2C8 within 14
days before initiation of therapy. Concomitant medications that are substrates of
BCRP with a narrow therapeutic index within 14 days before initiation of therapy.
9. Patient is pregnant or lactating, or plans to become pregnant in the immediate
future.
10. Patient has any clinically significant skin toxicity at screening, that in the
opinion of the investigator would increase risk of severe skin toxicity when using
investigational product.
11. There are other unspecified reasons that, in the opinion of the HCP, make the
patient unsuitable for enrollment.
12. Patient has CTCAE v5.0 Grade ≥3, CPK elevation ( > 5x UL - 10 X ULN)
Gender:
All
Minimum age:
6 Months
Maximum age:
25 Years
Lead sponsor:
Agency:
Day One Biopharmaceuticals, Inc.
Agency class:
Industry
Source:
Day One Biopharmaceuticals, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05760586
