Clinical trialNCT03107988CompletedPhase 1Interventional

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

SponsorNew Approaches to Neuroblastoma Therapy ConsortiumEnrollment65Neuroblastoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Yael Mosse, MD
Children's Hospital of Philadelphia
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Hospital for Sick Children
Toronto, Ontario, Canada

France

Institut Curie
Paris, Cedex, France

United Kingdom

Royal Marsden Hospital
Sutton, Surrey, United Kingdom

United States

Children'S Hospital Los Angeles
Los Angeles, California, United States
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Children Hospital of Colorado
Aurora, Colorado, United States
Children'S Healthcare of Atlanta
Atlanta, Georgia, United States
University of Chicago, Comer Children'S Hospital
Chicago, Illinois, United States
Childrens Hospital Boston, Dana-Farber Cancer Institute.
Boston, Massachusetts, United States
C.S Mott Children'S Hospital
Ann Arbor, Michigan, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children'S Healthcare System
Fort Worth, Texas, United States
Children'S Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cyclophosphamide →Filgrastim →Lorlatinib →Topotecan →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 5 Sept 2017
Primary completion: 22 Aug 2024
Completion: 31 Jan 2025
Last update posted: 15 Sept 2025
Registered enrollment: 65
Registry id: NCT03107988

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.