NCT00400569 · STUDY IN CONTEXT

Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).

All participants assessable for response

→

secondary · POSTED

Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).

All participants who completed the study

→

secondary · POSTED

The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.

All participants who completed the study

→

secondary · POSTED

Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.

All Participants

→

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-soft-tissue-sarcoma-metastatic-30f77ca0
nct id: NCT00400569
trial label: Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
applicability: unclear
applicability note: Attached because the study's own record describes metastatic 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: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0000
source section id
NCT00400569-om-0000
source outcome index
0
endpoint
Number of Participants With Overall Response (OR)
endpoint definition
Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
time origin
From On Treatment to Off Study - average of 6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants assessable for response
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-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0001
source section id
NCT00400569-om-0001
source outcome index
1
endpoint
Participants' Progression Free Survival (PFS)
endpoint definition
Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
time origin
From On Treatment to Off Study - average of 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants who completed the study
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-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0002
source section id
NCT00400569-om-0002
source outcome index
2
endpoint
Participants' Overall Survival (OS)
endpoint definition
The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.
time origin
From On Treatment to Off Study - average of 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants who completed the study
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-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0003
source section id
NCT00400569-om-0003
source outcome index
3
endpoint
Number of Participants With Serious Adverse Events (SAEs)
endpoint definition
Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.
time origin
4 years, 7 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Participants
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-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0000
arm key
OG000
arm label
Experimental: Sunitinib Malate (SU011248) Treatment
regimen
Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
analyzed count
43
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00400569-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0001
arm key
OG000
arm label
Liposarcoma Cohort Only
regimen
Experimental: Sunitinib Malate (SU011248) Treatment
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00400569-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0001
arm key
OG001
arm label
Leiomyosarcoma Cohort Only
regimen
Experimental: Sunitinib Malate (SU011248) Treatment
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00400569-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0001
arm key
OG002
arm label
Malignant Fibrous Histiocytoma (MFH) Cohort Only
regimen
Experimental: Sunitinib Malate (SU011248) Treatment
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00400569-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0002
arm key
OG000
arm label
Liposarcoma Cohort Only
regimen
Experimental: Sunitinib Malate (SU011248) Treatment
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00400569-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0002
arm key
OG001
arm label
Leiomyosarcoma Cohort Only
regimen
Experimental: Sunitinib Malate (SU011248) Treatment
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00400569-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0002
arm key
OG002
arm label
Malignant Fibrous Histiocytoma (MFH) Cohort Only
regimen
Experimental: Sunitinib Malate (SU011248) Treatment
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00400569-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
outcome key
om-0003
arm key
OG000
arm label
Experimental: Sunitinib Malate (SU011248) Treatment
regimen
Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
analyzed count
48
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00400569-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma-metastatic-30f77ca0
nct id
NCT00400569
harm key
EG000
source section id
NCT00400569-ae
event group key
EG000
event group label
Experimental: Sunitinib Malate (SU011248) Treatment
serious affected
13
serious at risk
48
other affected
39
other at risk
48
frequency threshold
5
collection period
4 years, 7 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