Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04753658
• Other study ID #: B7461036
• Status: Terminated
• Start date: March 19, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• lorlatinib
Oral

Locations

Country	Name	City	State
Australia	ST0683AU - Chris O'Brien Lifehouse	Camperdown, New South Wales, 2050 Australia
Australia	Westmead Hospital	Westmead	New South Wales
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Samsung medical Center	Seoul
New Zealand	Starship Blood and Cancer Centre	Auckland
Portugal	Instituto Portugues de Oncologia de Lisboa	Lisboa
Sweden	Queen Silvia Children's Hospital	Gothenburg
Sweden	HRH Crown Princess Victoria's Children and Youth Hospital	Linkoping
Sweden	Karolinska Institutet	Stockholm
Sweden	Norrland University Hospital	Umea
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Korea, Republic of,  New Zealand,  Portugal,  Sweden, 

Outcome

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

External Links

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