DAY101 In Gliomas and Other Tumors

Completed · Phase 1

Conditions studied: Low-grade Glioma

In brief

This research study is studying a drug Tovorafenib/DAY101 (formerly TAK-580, MLN2480) as a possible treatment a low-grade glioma that has not responded to other treatments. The name of the study drug involved in this study is: • Tovorafenib/DAY101 (formerly TAK-580, MLN2480)

Key facts

Study ID

NCT03429803

Run by

Karen D. Wright, MD

People needed

44

Starts

2018-02-27

Expected to finish

2025-12-31

Last updated by the study team

2026-02-19

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Phase I
• Pediatric patients with radiographically recurrent or radiographically progressive non-hematologic malignancies (Central Nervous System (CNS) or solid tumors) associated with activation of the RAS/RAF/MEK/ERK pathway will be eligible with the exception of patients with NF1.
• Mutational status requires a pathology report, genomic sequencing, or immunohistochemical report of a mutation or activation of the RAS/RAF/MEK/ERK pathway.
• The remaining criteria include:
• Patients must be >1 year and <25 years old.
• Patients must have adequate performance status:
• Karnofsky ≥ 50 for patients ≥ 16 years of age (See Appendix A).
• Lansky ≥ 50 for patients < 16 years of age (See Appendix A).
• Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score (See Appendix A).
• A patient who has failed standard therapy. Note: standard of care for resectable low grade glioma, as an example, is surgery. Therefore, patients with low grade glioma that recurs after presumed gross total resection may enroll without prior chemotherapy exposure.
• At least 1 measurable lesion that can be reproducibly measured in 2 dimensions
• Previous chemotherapy and hormone therapy (excluding physiologic replacement) must be completed at least 4 weeks or 4 half-lives, whichever is longer, prior to administration of DAY101.
• Previous immunotherapy/ monoclonal antibody use must be completed at least 4 weeks or 4 half lives, whichever is longer prior to administration of DAY101.
• Previous MEK or BRAF inhibitors must be completed at least 7 days prior to the administration of DAY101.
• Focal or cranial spinal irradiation to the target lesion (whether as treatment or palliation) must be completed at least 6 months prior to administration of DAY101 to address the possibility of pseudoprogression. If pseudoprogression is definitively ruled out with tissue sampling (biopsy or repeat surgery), the patient may enroll after completion of radiation therapy at time of defined progression (and not wait 6 months) as long as patient meets other eligibility requirements.
• All associated toxicities from previous therapies must be resolved to ≤ Grade 1 or considered baseline prior to administration of DAY101.
• Female patients who:
• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer as mandated by local labeling [e.g., United States Protection and Investigations (USPI), Summary of Product Characteristics (SmPC), etc,]) after the last dose of study drug, OR
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
• Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
• Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's National Hospital — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massacusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institite — Boston, Massachusetts, United States
• Children's Minnesota — Minneapolis, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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