- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05760586
Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Glioma
January 30, 2024 updated by: Day One Biopharmaceuticals, Inc.
Expanded Access to the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Relapsed or Refractory Low-Grade Glioma
The DAY101-EAP is a multicenter, open-label, expanded access treatment protocol designed to provide access to tovorafenib (DAY101) for eligible patients.
Study Overview
Study Type
Expanded Access
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: WEP Clinical
- Phone Number: 919-694-5088
- Email: day101eap@wepclinical.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for enrollment in the EAP:
- 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.
- 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.
- Patients must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.
- 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.
- Chronic toxicities from prior anticancer therapy must be stable and at CTCAE Version 5.0 Grade ≤ 2.
- Patients must have fully recovered from any prior surgery.
Patients must have adequate hematologic function, as defined by the following:
- Absolute neutrophil count≥ 1000/mm3
- Platelet count≥ 75.0 × 109/L
- Hemoglobin≥ 10.0 g/dL (transfusions allowed up to 14 days prior to enrollment per institutional guidelines)
Patients must have adequate hepatic and renal function, defined by the following:
- 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)
- Serum glutamic-pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≤ 3 × ULN
- Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate transaminase (AST) ≤ 3 × ULN
- Serum creatinine within normal limits, or estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 based on local institutional practice for determination
- Thyroid function tests must be consistent with stable thyroid function.
- Patients must be able to comply with treatment, laboratory monitoring, and required clinic visits for the duration of EAP participation.
- Male and female patients with reproductive potential must be willing to use birth control methods per Appendix E of protocol.
- Patients must be able to swallow tablets or liquid or administer through gastric access via feeding tube(12Fr or greater)
- 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:
- 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).
- Patient has known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.
- Patient has history of any major disease, other than the primary malignancy under EAP, that might interfere with safe protocol participation.
- 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).
- 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.
- Patient has an active systemic bacterial, viral, or fungal infection.
- Patient has malabsorption requiring supplementation, or significant bowel or stomach resection that would preclude adequate absorption of tovorafenib (DAY101).
- 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.
- Patient is pregnant or lactating, or plans to become pregnant in the immediate future.
- 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.
- There are other unspecified reasons that, in the opinion of the HCP, make the patient unsuitable for enrollment.
- Patient has CTCAE v5.0 Grade ≥3, CPK elevation ( > 5x UL - 10 X ULN)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 2, 2023
First Submitted That Met QC Criteria
February 23, 2023
First Posted (Actual)
March 8, 2023
Study Record Updates
Last Update Posted (Estimated)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAY101-EAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low-grade Glioma
-
St. Jude Children's Research HospitalSpringWorks Therapeutics, Inc.RecruitingLow-Grade Glioma | Recurrent Low-Grade Glioma | Progressive Low-Grade GliomaUnited States
-
National Cancer Institute (NCI)RecruitingLow Grade Glioma | Low Grade Astrocytoma | Metastatic Low Grade Astrocytoma | Metastatic Low Grade GliomaUnited States, Canada, Puerto Rico
-
National Cancer Institute (NCI)RecruitingRecurrent WHO Grade 2 Glioma | Recurrent Low Grade Astrocytoma | Refractory Low Grade Astrocytoma | Refractory Low Grade Glioma | Refractory WHO Grade 1 GliomaUnited States, Canada
-
Children's Hospital of PhiladelphiaBlue Earth Diagnostics; Dragon Master FoundationNot yet recruitingGlioma | Low-grade Glioma | Glioma, Malignant | Low Grade Glioma of Brain | Glioma IntracranialUnited States
-
Neurological Associates of West Los AngelesEnrolling by invitationLow Grade Glioma of BrainUnited States
-
National Cancer Institute (NCI)RecruitingGlioma | High Grade Glioma | Malignant Glioma | Gliomas | Low Grade GliomaUnited States
-
Maastricht Radiation OncologyMaastricht University Medical Center; Ziekenhuis Oost-Limburg; Zuyderland Medisch...Active, not recruitingHigh Grade Glioma | Low-grade GliomaNetherlands
-
University of California, San FranciscoBeiGene USA, Inc.; Pacific Pediatric Neuro-Oncology ConsortiumRecruitingGlioblastoma | Malignant Glioma | Recurrent Glioblastoma | Recurrent WHO Grade III Glioma | WHO Grade III Glioma | IDH2 Gene Mutation | IDH1 Gene Mutation | Low Grade Glioma | Recurrent WHO Grade II Glioma | WHO Grade II GliomaUnited States
-
Hospital del Río HortegaCompletedGlioma | Glioblastoma | Low-grade Glioma | Glioma, Malignant | High-grade GliomaSpain
-
Massachusetts General HospitalNational Cancer Institute (NCI)Active, not recruitingLow Grade Glioma | WHO Grade 3 Glioma With IDH1 Mutation | WHO Grade 3 Glioma With 1p/19q CodeletionUnited States
Clinical Trials on Tovorafenib
-
Day One Biopharmaceuticals, Inc.RecruitingMelanoma | Colorectal Cancer | Solid Tumor | Non Small Cell Lung Cancer | Bladder Cancer | Thyroid Cancer, Papillary | Pilocytic Astrocytoma | Bladder Urothelial Carcinoma | Non-Small Cell Adenocarcinoma | MEK Mutation | RAS Mutation | Pancreatic Acinar Carcinoma | RAF Mutation | CRAF Gene Amplification | RAF1 Gene Amplification and other conditionsUnited States, Canada, Korea, Republic of, Spain, Australia, Belgium, France
-
Sabine Mueller, MD, PhDBristol-Myers Squibb; Day One Biopharmaceuticals, Inc.RecruitingCraniopharyngioma | Craniopharyngioma, Child | Recurrent CraniopharyngiomaUnited States
-
Day One Biopharmaceuticals, Inc.SIOPe Brain Tumor Group LOGGIC ConsortiumRecruitingLow-grade GliomaUnited States, Korea, Republic of, France, Germany, Spain, United Kingdom, Belgium, Denmark, Canada, Italy, Finland, Australia, Ireland, Switzerland, Netherlands, Czechia, Greece, New Zealand, Slovenia, Sweden, Hungary, Singapore, A... and more
-
Daniel MorgensternThe Hospital for Sick ChildrenRecruiting
-
Children's Oncology GroupNot yet recruitingRecurrent Langerhans Cell Histiocytosis | Refractory Langerhans Cell Histiocytosis
-
National Cancer Institute (NCI)RecruitingRecurrent Langerhans Cell Histiocytosis | Refractory Langerhans Cell HistiocytosisUnited States, Canada