TriangleNCT00400569 · STUDY IN CONTEXT
Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
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 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).
The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.
Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.
Reported safety
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-liposarcoma
- nct id
- NCT00400569
- trial label
- Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma
- 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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-liposarcoma
- 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