TriangleNCT00753688 · STUDY IN CONTEXT
Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy
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 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
PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.
OS was defined as the time from the date of randomization to the date of death due to any cause. The length of this interval was calculated as the date of death minus the date of randomization plus 1 day. Participants who were alive at the time of analysis were censored at the date of last follow-up. The interim OS analysis was conducted when 215 (77 percent \[%\]) of the 279 required death events had occurred in the study. The Kaplan-Meier method was used for OS estimates.
Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a \>=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a \>=20% increase in the sum of the LD of TLs, or the appearance of \>=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of \>=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).
Time to response was defined as the time from the date of randomization until the date of first documented evidence of CR or PR (whichever status was recorded first). The Kaplan-Meier method was used for time to response estimates.
Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.
PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization \[WHO\] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.
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-soft-tissue-sarcoma
- nct id
- NCT00753688
- trial label
- Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy
- 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
- 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
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0000
- source section id
- NCT00753688-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.
- time origin
- From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat (ITT) Population: all randomized participants analyzed in the treatment arm they were allocated by randomization.
- 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
- nct id
- NCT00753688
- outcome key
- om-0001
- source section id
- NCT00753688-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from the date of randomization to the date of death due to any cause. The length of this interval was calculated as the date of death minus the date of randomization plus 1 day. Participants who were alive at the time of analysis were censored at the date of last follow-up. The interim OS analysis was conducted when 215 (77 percent \[%\]) of the 279 required death events had occurred in the study. The Kaplan-Meier method was used for OS estimates.
- time origin
- From the date of randomization until 215 deaths (assessed for an average of 12 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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
- nct id
- NCT00753688
- outcome key
- om-0002
- source section id
- NCT00753688-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator
- endpoint definition
- Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a \>=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a \>=20% increase in the sum of the LD of TLs, or the appearance of \>=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of \>=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).
- time origin
- From the start of treatment until disease progression (assessed for an average of 10 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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
- nct id
- NCT00753688
- outcome key
- om-0003
- source section id
- NCT00753688-om-0003
- source outcome index
- 3
- endpoint
- Time to Response Assessed by an Independent Radiologist and the Investigator
- endpoint definition
- Time to response was defined as the time from the date of randomization until the date of first documented evidence of CR or PR (whichever status was recorded first). The Kaplan-Meier method was used for time to response estimates.
- time origin
- From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.
- 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
- nct id
- NCT00753688
- outcome key
- om-0004
- source section id
- NCT00753688-om-0004
- source outcome index
- 4
- endpoint
- Duration of Response Assessed by the Independent Radiologist and the Investigator
- endpoint definition
- Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.
- time origin
- From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.
- 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
- nct id
- NCT00753688
- outcome key
- om-0005
- source section id
- NCT00753688-om-0005
- source outcome index
- 5
- endpoint
- PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)
- endpoint definition
- PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization \[WHO\] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.
- time origin
- From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population. The "n"s in the category titles represent the number of participants in each treatment arm with the indicated STS.
- 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
- nct id
- NCT00753688
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Placebo
- regimen
- Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Pazopanib
- regimen
- Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 246
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Placebo
- regimen
- Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Pazopanib
- regimen
- Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 246
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Placebo
- regimen
- Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Pazopanib
- regimen
- Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 246
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Placebo
- regimen
- Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Pazopanib
- regimen
- Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Placebo
- regimen
- Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Pazopanib
- regimen
- Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Placebo
- regimen
- Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Pazopanib
- regimen
- Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
- analyzed count
- 246
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00753688-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma
- nct id
- NCT00753688
- harm key
- EG000
- source section id
- NCT00753688-ae
- event group key
- EG000
- event group label
- Placebo
- serious affected
- 29
- serious at risk
- 123
- other affected
- 108
- other at risk
- 123
- frequency threshold
- 5
- collection period
- Serious adverse events (SAEs) and non-serious AEs were collected from Baseline through End of Study (average of 20 study weeks).
- event definition
- The Safety Population, comprised of all participants who had started their allocated treatment (at least one dose of the study drug), was used for all safety analyses.
- 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-soft-tissue-sarcoma
- nct id
- NCT00753688
- harm key
- EG001
- source section id
- NCT00753688-ae
- event group key
- EG001
- event group label
- Pazopanib
- serious affected
- 99
- serious at risk
- 240
- other affected
- 232
- other at risk
- 240
- frequency threshold
- 5
- collection period
- Serious adverse events (SAEs) and non-serious AEs were collected from Baseline through End of Study (average of 20 study weeks).
- event definition
- The Safety Population, comprised of all participants who had started their allocated treatment (at least one dose of the study drug), was used for all safety analyses.
- 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