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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: Completed Phase 1 study, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT03107988 is a Phase 1 study that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A1
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 |
What the finished NCT03107988 record still lists
NCT03107988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03107988 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03107988's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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