Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04753658

Collaborator

(none)

Enrollment

Locations

32.3

Anticipated Duration (Months)

16.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Drug: lorlatinib

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

REAL WORLD DATA COLLECTION AMONG PEDIATRIC NEUROBLASTOMA PATIENTS TREATED WITH LORLATINIB THROUGH EXPANDED ACCESS PROGRAM

Actual Study Start Date :

Apr 21, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Pediatric Neuroblastoma Patients Treated with Lorlatinib	Drug: lorlatinib Oral

Arm

Intervention/Treatment

Pediatric Neuroblastoma Patients Treated with Lorlatinib

Drug: lorlatinib

Oral

Outcome Measures

Primary Outcome Measures

Objective tumor response of primary tumor (soft tissue), soft tissue metastasis, and bone metastasis [March 2017- December 2023]
Bone marrow response [March 2017-December 2023]
Health care professional (HCP) Reported Objective Response [March 2017-December 2023]
Derived Objective Response [March 2017-December 2023]
Best Overall response [March 2017-December 2023]
Overall Response Rate (ORR) [March 2017-December 2023]
Duration of response [March 2017-December 2023]
Progression free survival (PFS) [March 2017-December 2023]
Duration of treatment [March 2017-December 2023]
Overall survival (OS) [March 2017-December 2023]
The number of patients reporting Adverse Events (AE) [March 2017-December 2023]
The percentage of patients reporting Adverse Events (AE) [March 2017-December 2023]
The number of patients reporting treatment related Adverse Events (AE) [March 2017-December 2023]
The percentage of patients reporting treatment related Adverse Events (AE) [March 2017-December 2023]
The number of patients reporting Serious Adverse Events (SAE) [March 2017-December 2023]
The percentage of patients reporting treatment related Serious Adverse Events (SAE) [March 2017-December 2023]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient receives lorlatinib through Pfizer's expanded access program for treatment of ALK+ neuroblastoma.
HCP documentation of at least one tumor assessment of response after patient has had at least one dose of lorlatinib
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Any patient who does not meet any of the inclusion criteria defined in the previous section.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania	United States	19104
2	Asan Medical Center	Seoul		Korea, Republic of	05505
3	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT04753658

Other Study ID Numbers:

B7461036

First Posted:

Feb 15, 2021

Last Update Posted:

Apr 7, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Neuroblastoma

Study Results

No Results Posted as of Apr 7, 2022