NCT03107988 · STUDY IN CONTEXT

NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A1

Source null

→

primary · POSTED

Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A2

Source null

→

primary · POSTED

Proportion of patients with course 1 DLT in cohort B2

Source null

→

primary · POSTED

Proportion of patients with any grade 3 or greater non-hematological toxicities on any course in A1 and B1

Source null

→

primary · POSTED

Proportion of patients with any grade 3 or greater hematological toxicities on any course in A1 and B1

Source null

→

primary · POSTED

Proportion of patients with any grade 3 or greater non-hematological toxicities in A2

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-neuroblastoma
nct id: NCT03107988
trial label: NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 13
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0000
source section id
NCT03107988-om-0000
source outcome index
0
endpoint
MTD/RP2D Determination A1
endpoint definition
Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A1
time origin
All toxicities from enrollment until completion of course 2 (Day 56)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0001
source section id
NCT03107988-om-0001
source outcome index
1
endpoint
MTD/RP2D Determination A2
endpoint definition
Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A2
time origin
All toxicities from enrollment until completion of course 2 (Day 56)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0002
source section id
NCT03107988-om-0002
source outcome index
2
endpoint
MTD/RP2D Determination B2
endpoint definition
Proportion of patients with course 1 DLT in cohort B2
time origin
All toxicities from enrollment until completion of course 1 (Day 28)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0003
source section id
NCT03107988-om-0003
source outcome index
3
endpoint
Describe Non-Hematological Toxicities (A1 and B1)
endpoint definition
Proportion of patients with any grade 3 or greater non-hematological toxicities on any course in A1 and B1
time origin
All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0004
source section id
NCT03107988-om-0004
source outcome index
4
endpoint
Describe Hematological Toxicities (A1 and B1)
endpoint definition
Proportion of patients with any grade 3 or greater hematological toxicities on any course in A1 and B1
time origin
All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0005
source section id
NCT03107988-om-0005
source outcome index
5
endpoint
Describe Non-Hematological Toxicities (A2)
endpoint definition
Proportion of patients with any grade 3 or greater non-hematological toxicities in A2
time origin
All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0000
arm key
OG000
arm label
Cohort A1 DL1
regimen
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0000
arm key
OG001
arm label
Cohort A1 DL2
regimen
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0000
arm key
OG002
arm label
Cohort A1 DL3
regimen
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0000
arm key
OG003
arm label
Cohort A1 DL4
regimen
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0000
arm key
OG004
arm label
Cohort A1 DL5
regimen
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0001
arm key
OG000
arm label
Cohort A2 DL 3A
regimen
Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0001
arm key
OG001
arm label
Cohort A2 DL4A
regimen
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0001
arm key
OG002
arm label
Cohort A2 DL4A Expansion
regimen
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0002
arm key
OG000
arm label
Cohort B2 DL4B
regimen
Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0002
arm key
OG001
arm label
Cohort B2 DL5B
regimen
Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0002
arm key
OG002
arm label
Cohort B2 DL3A
regimen
Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
outcome key
om-0002
arm key
OG003
arm label
Cohort B2 DL4A
regimen
Lorlatinib will be given orally once daily continuously for 28 days at 150mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03107988-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG000
source section id
NCT03107988-ae
event group key
EG000
event group label
Cohort A1 DL1
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG001
source section id
NCT03107988-ae
event group key
EG001
event group label
Cohort A1 DL2
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG002
source section id
NCT03107988-ae
event group key
EG002
event group label
Cohort A1 DL3
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG003
source section id
NCT03107988-ae
event group key
EG003
event group label
Cohort A1 DL4
serious affected
3
serious at risk
10
other affected
9
other at risk
10
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG004
source section id
NCT03107988-ae
event group key
EG004
event group label
Cohort A1 DL5
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG005
source section id
NCT03107988-ae
event group key
EG005
event group label
Cohort A2 DL 3A
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG006
source section id
NCT03107988-ae
event group key
EG006
event group label
Cohort A2 DL4A
serious affected
3
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG007
source section id
NCT03107988-ae
event group key
EG007
event group label
Cohort A2 DL4A Expansion
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG008
source section id
NCT03107988-ae
event group key
EG008
event group label
Cohort B1 DL5
serious affected
3
serious at risk
5
other affected
5
other at risk
5
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG009
source section id
NCT03107988-ae
event group key
EG009
event group label
Cohort B2 DL4B
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG010
source section id
NCT03107988-ae
event group key
EG010
event group label
Cohort B2 DL5B
serious affected
10
serious at risk
13
other affected
12
other at risk
13
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroblastoma
nct id
NCT03107988
harm key
EG011
source section id
NCT03107988-ae
event group key
EG011
event group label
Cohort B2 DL3A
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice