Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis A COG Groupwide Phase 2 Study
Contact:
NCT Number:
Protocol:
AAAV0191
Study Status:
Active/Enrolling
Population:
Pediatrics/Adult
Phase:
II
This trial is an open-label, multi-center Phase 2 study to evaluate the safety and efficacy of the pan-RAF inhibitor DAY101 in patients with relapsed/refractory LCH. The primary aim is to determine overall response rate for children and young adults with relapsed or refractory LCH treated with tovorafenib (DAY101) after 2 cycles and must be maintained 4 weeks later.
Are you Eligible? (Inclusion Criteria)
- Age at diagnosis: 180 days- <22 years (at time of study enrollment) -Patients with multifocal progressive, relapsed, or recurrent LCH with measurable disease at study entry -Patients must have progressive or refractory disease or experience relapse after at least one previous systemic chemotherapy treatment strategy -Patient must meet all eligibility criteria as outlined in the study protocol.
Specialty Area(s)
Childhood and Adolescent Cancers (Pediatric)
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032

