DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
M
Michael Ferguson, MD
Primary Investigator
Enrolling By Invitation
25 years and younger
All
Phase
3
400 participants needed
2 Locations
Overview
What is the purpose of this study?
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the
efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC)
chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating
rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Description
What will happen during the study?
- Approximately 400 treatment-naïve low-grade glioma patients will be randomized 1:1 to either tovorafenib (Arm 1) or an Investigator's choice of SoC chemotherapy (Arm 2).
- Arm 1 (tovorafenib): treatment cycles will repeat every 28 days in the absence of disease progression. Patients will continue tovorafenib until any of the following occurs: disease progression based on Response Assessment in Neuro-Oncology (RANO-LGG) criteria, unacceptable toxicity, withdrawal of consent to treatment, or end of study.
- Arm 2 (Investigator's Choice of SoC Chemotherapy): patients will receive one of 3 SoC chemotherapy options selected by the treating Investigator: Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) regimen, International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) regimen, or vinblastine (VBL) regimen. The choice of SoC chemotherapy regimen will be selected prior to patient randomization. Treatment will continue until completion of therapy or until any of the following occurs: disease progression based on RANO-LGG criteria, unacceptable toxicity, withdrawal of consent to treatment, or end of study.
- Patients who discontinue treatment due to disease progression will have (1) radiographic evidence of progressive disease based on RANO-LGG, as determined by the Investigator and confirmed by the IRC, or (2) clinical progression based on RANO-LGG criteria determined by the Investigator. Investigators are encouraged to discuss cases of clinical progression and early radiographic progression without clinical symptom with the Sponsor Medical Monitor prior to treatment discontinuation or initiation of a different form of treatment for the malignancy.
- Patients may continue therapy beyond progressive disease
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Low-grade Glioma, Riley
-
Age: - 25 Years
-
Gender: All
Inclusion Criteria:
- Less than 25 years of age with LGG with known activating RAF alteration
- Histopathologic diagnosis of glioma or glioneuronal tumor
- At least one measurable lesion as defined by RANO criteria
- Meet indication for first-line systemic therapy
Exclusion Criteria:
- Patient has any of the following tumor-histological findings:
- Schwannoma
- Subependymal giant cell astrocytoma (Tuberous Sclerosis)
- Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
- Patient's tumor has additional pathogenic molecular alterations
- Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF-1/NF-2)
- Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/intravenous targeted therapy) including radiation
Updated on
12 Sep 2024.
Study ID: DAY101-002, PHO-DOB-FIREFLY-2, 18764
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