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NCT04753658 · ClinicalTrials.gov registry record
Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib
A clinical trial, sponsored by Pfizer.
- Terminated
- Registry status
- 15
- Enrollment target
NCT04753658: Clinical Trial study, sponsored by Pfizer.
NCT04753658 is a clinical trial that was terminated before completion, run by Pfizer. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04753658 was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
Tumor response was collected by the data collection tool (DCT) and responses included complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). As per International Neuroblastoma Response Criteria (INRC): CR=\<10 millimeter (mm) residual soft tissue at primary site and complete resolution of metaiodobenzylguanidine (MIBG) or \[18F\] fluorodeoxyglucose (FDG)/positron emission tomography (PET) uptake (for MIBG-nonavid tumors) at primary site; PR: \>=30% decre
Interventions
- DRUG lorlatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-03-19 |
| Est. Completion | 2022-09-30 |
Why NCT04753658 stopped before completion
NCT04753658 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which lorlatinib is the first listed.
NCT04753658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04753658 about?
NCT04753658 is a clinical study titled "Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib". 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.
What is the current status of trial NCT04753658?
This trial is currently terminated. The enrollment target is 15 participants. The study started on 2021-03-19. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT04753658?
The interventions under investigation include: lorlatinib (DRUG).
Who is sponsoring clinical trial NCT04753658?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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