NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib.
In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single
agent and in combination with chemotherapy in patients with relapsed/refractory
neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I
3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6
patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be
initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort
A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2).
Phase:
Phase 1
Details
Lead Sponsor:
New Approaches to Neuroblastoma Therapy Consortium
Collaborators:
Children's Neuroblastoma Cancer Foundation Cookies for Kids' Cancer Pfizer Ronan Thompson Foundation Solving Kids' Cancer US/EU The Band of Parents The Catherine Elizabeth Blair Memorial Foundation The Evan Foundation University of Southern California Wade's Army