NCT01502410 · STUDY IN CONTEXT

Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer

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

Response rates will be calculated as the number of evaluable patients who are responders. Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Only Rhabdomyosarcoma and Wilms Tumor patients are included in this analysis as there were no accruals on Hepatocellular carcinoma and no accruals on Thyroid carcinoma.

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secondary · POSTED

Percent probability of being progression free six months following enrollment. Progression-free interval (PFI) will be calculated as the date of enrollment until the end PFI date, where that date is calculated as the date of disease progression, date of death, date of removal of all tumors by surgery or last patient contact, whichever occurs first.

All eligible patients are included in this analysis for both Rhabdomyosarcoma and Wilms Tumor. However, there were no accruals on the disease arms for Hepatocellular carcinoma and Papillary Thyroid carcinoma and were not included in this analysis.

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secondary · POSTED

Each patient is classified as having experienced grade 3 or higher CTC version 4 toxicity if at any time during protocol therapy such an event is observed for the individual.

All eligible patients diagnosed with Rhabdomyosarcoma or Wilms Tumor are combined in this analysis.

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secondary · POSTED

The trough sorafenib concentration is evaluated at baseline (prior to administration of Sorafenib) and 12 hours after administration of Sorafenib on day 15, day 56, day 112 and day 168 in micrograms/ml.

Baseline sample was available for only 9 participants.

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secondary · POSTED

Serum VEGF and VEGF receptor 2 Concentration is evaluated at baseline and at day 15 of protocol therapy in picograms/ml.

Change in VEGF and VEGFR-2 are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular disease with which the patient was diagnosed, and were combined for analysis.

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secondary · POSTED

Descriptive statistics including mean, median, standard deviation, and range will be calculated for baseline for patients with PTC, TG and TG antibody, and presence of BRAF mutation or RET/PTC rearrangement.

No patients were enrolled with PTC (papillary thyroid carcinoma) so there are no patients who can contribute to this outcome measure.

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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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id: NCT01502410
trial label: Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer
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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0000
source section id
NCT01502410-om-0000
source outcome index
0
endpoint
Objective Response by RECIST Criteria v 1.1
endpoint definition
Response rates will be calculated as the number of evaluable patients who are responders. Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
time origin
6 cycles (168 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only Rhabdomyosarcoma and Wilms Tumor patients are included in this analysis as there were no accruals on Hepatocellular carcinoma and no accruals on Thyroid carcinoma.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0001
source section id
NCT01502410-om-0001
source outcome index
1
endpoint
Progression-free Survival According to RECIST Version 1.1
endpoint definition
Percent probability of being progression free six months following enrollment. Progression-free interval (PFI) will be calculated as the date of enrollment until the end PFI date, where that date is calculated as the date of disease progression, date of death, date of removal of all tumors by surgery or last patient contact, whichever occurs first.
time origin
Six months after enrollment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients are included in this analysis for both Rhabdomyosarcoma and Wilms Tumor. However, there were no accruals on the disease arms for Hepatocellular carcinoma and Papillary Thyroid carcinoma and were not included in this analysis.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0002
source section id
NCT01502410-om-0002
source outcome index
2
endpoint
The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity,
endpoint definition
Each patient is classified as having experienced grade 3 or higher CTC version 4 toxicity if at any time during protocol therapy such an event is observed for the individual.
time origin
six cycles of chemotherapy; expected to be 126 days of treatment
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients diagnosed with Rhabdomyosarcoma or Wilms Tumor are combined in this analysis.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0003
source section id
NCT01502410-om-0003
source outcome index
3
endpoint
Pharmacokinetic (PK) Parameters of Sorafenib Tosylate
endpoint definition
The trough sorafenib concentration is evaluated at baseline (prior to administration of Sorafenib) and 12 hours after administration of Sorafenib on day 15, day 56, day 112 and day 168 in micrograms/ml.
time origin
Prior to administration of Sorafenib (baseline), day 15, day 56, day 112 and day 168
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Baseline sample was available for only 9 participants.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0004
source section id
NCT01502410-om-0004
source outcome index
4
endpoint
Change in VEGF and VEGFR-2
endpoint definition
Serum VEGF and VEGF receptor 2 Concentration is evaluated at baseline and at day 15 of protocol therapy in picograms/ml.
time origin
Prior to the administration of sorafenib (baseline) and day 15 of protocol therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Change in VEGF and VEGFR-2 are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular disease with which the patient was diagnosed, and were combined for analysis.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0005
source section id
NCT01502410-om-0005
source outcome index
5
endpoint
Presence of BRAF Mutation or RET/PTC Rearrangement
endpoint definition
Descriptive statistics including mean, median, standard deviation, and range will be calculated for baseline for patients with PTC, TG and TG antibody, and presence of BRAF mutation or RET/PTC rearrangement.
time origin
At baseline
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No patients were enrolled with PTC (papillary thyroid carcinoma) so there are no patients who can contribute to this outcome measure.
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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0000
arm key
OG000
arm label
Group 1 Relapsed/Refractory Rhabdomyosarcoma
regimen
Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0000
arm key
OG001
arm label
Group 2 Relapsed/Refractory Wilms Tumor
regimen
Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0001
arm key
OG000
arm label
Group 1 Relapsed/Refractory Rhabdomyosarcoma
regimen
Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0001
arm key
OG001
arm label
Group 2 Relapsed/Refractory Wilms Tumor
regimen
Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0002
arm key
OG000
arm label
Rhabdomyosarcoma and Wilms Tumor
regimen
These are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular diagnosed disease. Therefore, both Rhabdomyosarcoma and Wilms Tumor are combined in this analysis.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0003
arm key
OG000
arm label
Rhabdomyosarcoma and Wilms Tumor
regimen
Serum concentration are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular disease with which the patient was diagnosed and were combined for analysis.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0004
arm key
OG000
arm label
Rhabdomyosarcoma and Wilms Tumor
regimen
Rhabdomyosarcoma and Wilms Tumor
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0005
arm key
OG000
arm label
Group 1 Relapsed/Refractory Rhabdomyosarcoma
regimen
Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
outcome key
om-0005
arm key
OG001
arm label
Group 2 Relapsed/Refractory Wilms Tumor
regimen
Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28 pharmacological study: Optional correlative studies laboratory biomarker analysis: Optional correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01502410-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
harm key
EG000
source section id
NCT01502410-ae
event group key
EG000
event group label
Group 1 Relapsed/Refractory Rhabdomyosarcoma
serious affected
4
serious at risk
10
other affected
5
other at risk
10
frequency threshold
0
collection period
Source null
event definition
SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Only Grade 3 and higher Adverse Events were collected/assessed in this 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-rhabdomyosarcoma-pediatric-recurrent-f57bdf0f
nct id
NCT01502410
harm key
EG001
source section id
NCT01502410-ae
event group key
EG001
event group label
Group 2 Relapsed/Refractory Wilms Tumor
serious affected
3
serious at risk
10
other affected
6
other at risk
10
frequency threshold
0
collection period
Source null
event definition
SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Only Grade 3 and higher Adverse Events were collected/assessed in this 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