Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Number of patients with treatment-related dose limiting toxicities in cycle 1, as defined by study protocol, stratified by dose level.

There were 55 evaluable patients.

→

primary · POSTED

Number of patients with treatment-related adverse events stratified by dose level through study completion.

There were 55 evaluable patients.

→

primary · POSTED

Area under the plasma concentration versus time curve (AUC) of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.

Pharmacokinetic (PK) studies were completed for stratums I and II. Summary statistics for PK analysis was performed regardless of dose level as pre-specified in the protocol. PK was not performed in stratum III

→

primary · POSTED

Clearance of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.

→

primary · POSTED

Half-life of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.

Data was and never will be collected

→

primary · POSTED

Maximum serum concentration (Cmax) of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.

Data was not collected for patients from Part A:130 mg/m\^2

→

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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id: NCT01445080
trial label: Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 9
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
source section id
NCT01445080-om-0000
source outcome index
0
endpoint
Number of Patients With Treatment-related Dose Limiting Toxicity in Cycle 1 by Dose Level
endpoint definition
Number of patients with treatment-related dose limiting toxicities in cycle 1, as defined by study protocol, stratified by dose level.
time origin
Up to 28 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
There were 55 evaluable patients.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0001
source section id
NCT01445080-om-0001
source outcome index
1
endpoint
Number of Patients With Treatment-related Adverse Events
endpoint definition
Number of patients with treatment-related adverse events stratified by dose level through study completion.
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
There were 55 evaluable patients.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0002
source section id
NCT01445080-om-0002
source outcome index
2
endpoint
Area Under the Plasma Concentration Versus Time Curve (AUC) of Sorafenib
endpoint definition
Area under the plasma concentration versus time curve (AUC) of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.
time origin
During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic (PK) studies were completed for stratums I and II. Summary statistics for PK analysis was performed regardless of dose level as pre-specified in the protocol. PK was not performed in stratum III
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0003
source section id
NCT01445080-om-0003
source outcome index
3
endpoint
Clearance (Cl) of Sorafenib
endpoint definition
Clearance of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.
time origin
During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic (PK) studies were completed for stratums I and II. Summary statistics for PK analysis was performed regardless of dose level as pre-specified in the protocol. PK was not performed in stratum III
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0004
source section id
NCT01445080-om-0004
source outcome index
4
endpoint
Half-life of Sorafenib
endpoint definition
Half-life of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.
time origin
During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Data was and never will be collected
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0005
source section id
NCT01445080-om-0005
source outcome index
5
endpoint
Maximum Serum Concentration (Cmax) of Sorafenib
endpoint definition
Maximum serum concentration (Cmax) of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.
time origin
During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Data was not collected for patients from Part A:130 mg/m\^2
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG000
arm label
Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
regimen
Patients receive oral sorafenib 105 mg/m\^2 every 12 hours.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG001
arm label
Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
regimen
Patients receive oral sorafenib 130 mg/m\^2 every 12 hours.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG002
arm label
Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
regimen
Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG003
arm label
Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
regimen
Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG004
arm label
Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
regimen
Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG005
arm label
Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
regimen
Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG006
arm label
Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
regimen
Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG007
arm label
Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
regimen
Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0000
arm key
OG008
arm label
PK Cohort Expanded: BAY 43-9006 200 mg/m^2
regimen
Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0001
arm key
OG000
arm label
Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
regimen
Patients receive oral sorafenib 105 mg/m\^2 every 12 hours.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0001
arm key
OG001
arm label
Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
regimen
Patients receive oral sorafenib 130 mg/m\^2 every 12 hours.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
outcome key
om-0001
arm key
OG002
arm label
Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
regimen
Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01445080-om-0001#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG000
source section id
NCT01445080-ae
event group key
EG000
event group label
Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
serious affected
7
serious at risk
7
other affected
7
other at risk
7
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG001
source section id
NCT01445080-ae
event group key
EG001
event group label
Part A: Refractory Solid Tumors: BAY 43-9006 130 mg/m^2
serious affected
5
serious at risk
5
other affected
5
other at risk
5
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG002
source section id
NCT01445080-ae
event group key
EG002
event group label
Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
serious affected
12
serious at risk
12
other affected
12
other at risk
12
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG003
source section id
NCT01445080-ae
event group key
EG003
event group label
Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
serious affected
8
serious at risk
8
other affected
8
other at risk
8
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG004
source section id
NCT01445080-ae
event group key
EG004
event group label
Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
serious affected
2
serious at risk
4
other affected
2
other at risk
4
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG005
source section id
NCT01445080-ae
event group key
EG005
event group label
Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
serious affected
9
serious at risk
9
other affected
9
other at risk
9
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG006
source section id
NCT01445080-ae
event group key
EG006
event group label
Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG007
source section id
NCT01445080-ae
event group key
EG007
event group label
Part C: Refractory AML With FLT3-ITD Mutation:150 mg/m^2
serious affected
5
serious at risk
5
other affected
5
other at risk
5
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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-acute-promyelocytic-leukemia-pediatric-recurrent-3d218272
nct id
NCT01445080
harm key
EG008
source section id
NCT01445080-ae
event group key
EG008
event group label
PK Cohort Expanded: BAY 43-9006 200 mg/m^2
serious affected
18
serious at risk
18
other affected
18
other at risk
18
frequency threshold
0
collection period
Up to 2 years
event definition
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
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