NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)

Active:	No
Cancer Type:	Neuroblastoma	NCT ID:	NCT03107988
Trial Phases:	Phase I	Protocol IDs:	NANT2015-02 (primary) NCI-2017-00943 N2015-02
Eligibility:	1 - 99 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	New Approaches to Neuroblastoma Treatment (NANT)
NCI Full Details:	http://clinicaltrials.gov/show/NCT03107988

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).

Objectives

Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib.
An adult phase 1 study established an RP2D of 100mg QD for lorlatinib. 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).

Lorlatinib will be administered orally via tablets or via oral dispersion if patient is
unable to swallow tablets whole

All patients will participate in mandatory pharmacokinetic testing.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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