Ignite Creation Date:
2024-05-06 @ 9:54 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03107988
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2017-03-21
Brief Title:
NANT 2015-02 A Phase 1 Study of Lorlatinib PF-06463922
Sponsor:
New Approaches to Neuroblastoma Therapy Consortium
Organization:
New Approaches to Neuroblastoma Therapy Consortium
Study Overview
Official Title:
Phase 1 Study of Lorlatinib PF-06463922 an Oral Small Molecule Inhibitor of ALKROS1 for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 relapsedrefractory neuroblastoma The dose escalation phase of this study Cohort A1 uses a traditional Phase I 33 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
Detailed Description:
Lorlatinib is a novel inhibitor across ALK variants including those resistant to crizotinib An adult phase 1 study established an RP2D of 100mg QD for lorlatinib 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 relapsedrefractory neuroblastoma The dose escalation phase of this study Cohort A1 uses a traditional Phase I 33 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
Lorlatinib will be administered orally via tablets or via oral dispersion if patient is unable to swallow tablets whole
All patients will participate in mandatory pharmacokinetic testing
Lorlatinib will be administered orally via tablets or via oral dispersion if patient is unable to swallow tablets whole
All patients will participate in mandatory pharmacokinetic testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None