Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

NCT ID: NCT04753658

Last Updated: 2024-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-19

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neuroblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Pediatric Neuroblastoma Patients Treated with Lorlatinib

lorlatinib

Intervention Type DRUG

Oral

Interventions

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lorlatinib

Oral

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

ST0683AU - Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050 Australia, , Australia

Site Status

Starship Blood and Cancer Centre

Auckland, , New Zealand

Site Status

Instituto Portugues de Oncologia de Lisboa

Lisbon, , Portugal

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Queen Silvia Children's Hospital

Gothenburg, , Sweden

Site Status

HRH Crown Princess Victoria's Children and Youth Hospital

Linköping, , Sweden

Site Status

Karolinska Institutet

Stockholm, , Sweden

Site Status

Norrland University Hospital

Umeå, , Sweden

Site Status

Countries

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United States Australia New Zealand Portugal South Korea Sweden

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7461036

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Other Identifiers

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B7461036

Identifier Type: -

Identifier Source: org_study_id

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