Request For Expanded Access Use Of Mirdametinib
Posted Date: Nov 10, 2020
- Investigator: Soma Sengupta
- Type of Study: Drug
Treatment for low grade gliomas in patients without NF1 includes radiation therapy or BRAF/MEK inhibitors for those with a BRAF V600E mutation. However, radiation therapy is known to cause complications in patients with NF1 including local swelling and increased incidence of secondary brain tumors, and only about 3% of patients with low grade gliomas secondary to NF1 harbor a BRAF mutation 2-4. The proposed treatment plan for AT mirrors that of the NCT03962543 study protocol: mirdametinib 2 mg/m2 (4 mg) orally twice daily for 3 weeks of each 28 day cycle (3 weeks on, 1 week off) for 24 cycles or as long as investigator determines patient is benefitting. Of note, AT has a history of left ventricular ejection fraction (LVEF) of 45%, which is an exclusion criteria for NCT03962543 and will be monitored on therapy. The benefit of therapy still exceeds this risk given that in previous studies with mirdametinib, decreases in LVEF were primarily seen with doses = 10 mg BID.
Criteria:
Null
Keywords:
Tectal Glioma, Mirdametinib, Nf1
For More Information:
Soma Sengupta
(513) 584-7824
sengupsm@ucmail.uc.edu