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NCT03107988 · ClinicalTrials.gov registry record · Phase 1
NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
A Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT03107988 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 65 participants.
The verdict
NCT03107988, a Phase 1 study, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Cyclophosphamide
- DRUG Topotecan
- DRUG Lorlatinib
- DRUG Filgrastim/pegfilgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-09-05 |
| Est. Completion | 2025-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03107988
The ClinicalTrials.gov registry entry for NCT03107988 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Approaches to Neuroblastoma Therapy Consortium, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03107988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03107988 about?
NCT03107988 is a clinical study titled "NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)". 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 ...
What is the current status of trial NCT03107988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2017-09-05. Estimated completion is 2025-01-31.
What interventions are being tested in trial NCT03107988?
The interventions under investigation include: Cyclophosphamide (DRUG), Topotecan (DRUG), Lorlatinib (DRUG), Filgrastim/pegfilgrastim (DRUG).
Who is sponsoring clinical trial NCT03107988?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
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