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 Healthcare of Atlanta
Arthur M. Blank Hospital
2220 North Druid Hills Road NE
Atlanta, GA 30329
404-785-0853
www.choa.org

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