Trial · NCT00753688
Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy
NCT00753688, Phase 3, Completed, GlaxoSmithKline; results first posted 2011-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy. Trials, record NCT00753688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00753688
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy
- NCT number
- NCT00753688
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 369 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Sarcoma, Soft Tissue
- Interventions
- PAZOPANIB, Placebo
- First posted
- 2008-09-16
- Last updated
- 2013-08-22
- Results first posted
- 2011-12-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 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) | 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. |
| Secondary | Overall Survival (OS) | From the date of randomization until 215 deaths (assessed for an average of 12 months) | 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. |
| Secondary | Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator | From the start of treatment until disease progression (assessed for an average of 10 months) | 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). |
| Secondary | Time to Response Assessed by an Independent Radiologist and the Investigator | From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months) | 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. |
| Secondary | Duration of Response Assessed by the Independent Radiologist and the Investigator | From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months) | 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. |
| Secondary | PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS) | 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) | 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. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104 | Change from baseline in on-therapy SBP and DBP was calculated as the values at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline. |
| Secondary | Change From Baseline in Heart Rate | Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104 | Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline. |
| Secondary | Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count | From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks) | Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported. |
| Secondary | Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin | From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks) | Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | 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) | Intent-to-Treat (ITT) Population: all randomized participants analyzed in the treatment arm they were allocated by randomization. | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of randomization until 215 deaths (assessed for an average of 12 months) | ITT Population | months | MEDIAN |
| SECONDARY | Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator | From the start of treatment until disease progression (assessed for an average of 10 months) | ITT Population | participants | NUMBER |
| SECONDARY | Time to Response Assessed by an Independent Radiologist and the Investigator | From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months) | 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. | weeks | MEDIAN |
| SECONDARY | Duration of Response Assessed by the Independent Radiologist and the Investigator | From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months) | 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. | weeks | MEDIAN |
| SECONDARY | PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS) | 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) | ITT Population. The ns in the category titles represent the number of participants in each treatment arm with the indicated STS. | weeks | MEDIAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104 | Safety Population: all participants who had started their allocated treatment (at least one dose of the study drug). Data were analyzed for participants who were on-therapy and provided data at the indicated time point. | Millimeters of mercury | MEAN |
| SECONDARY | Change From Baseline in Heart Rate | Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104 | Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point. | beats per minute | MEAN |
| SECONDARY | Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count | From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks) | Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin | From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks) | Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group298
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Placebo | 7.0 | 95% Confidence Interval 4.4 to 8.1 | weeks | |
| Progression-free Survival (PFS) | Pazopanib | 20.0 | 95% Confidence Interval 17.9 to 21.3 | weeks | |
| Overall Survival (OS) | Placebo | 10.7 | 95% Confidence Interval 9.0 to 13.1 | months | |
| Overall Survival (OS) | Pazopanib | 12.6 | 95% Confidence Interval 10.9 to 14.9 | months | |
| Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator | Placebo | CR, Independent radiologist assessed | 0 | participants | |
| Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator | Pazopanib | CR, Independent radiologist assessed | 0 | participants | |
| Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator | Placebo | PR, Independent radiologist assessed | 0 | participants | |
| Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator | Pazopanib | PR, Independent radiologist assessed | 11 | participants | |
| Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator | Placebo | SD, Independent radiologist assessed | 33 | participants | |
| Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator | Pazopanib | SD, Independent radiologist assessed | 134 | participants |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 123 | |
| Overall Study | STARTED | Pazopanib | 246 | |
| Overall Study | Ongoing - in Follow-up | Placebo | 15 | |
| Overall Study | Ongoing - in Follow-up | Pazopanib | 31 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Pazopanib | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 123 | |
| Overall Study | NOT COMPLETED | Pazopanib | 246 |
Source ClinicalTrials.gov
Adverse events332
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 27 | 123 | |
| other | Nausea | Gastrointestinal disorders | Pazopanib | 135 | 240 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 19 | 123 | |
| other | Diarrhea | Gastrointestinal disorders | Pazopanib | 141 | 240 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 14 | 123 | |
| other | Vomiting | Gastrointestinal disorders | Pazopanib | 81 | 240 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Placebo | 11 | 123 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Pazopanib | 57 | 240 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 21 | 123 | |
| other | Constipation | Gastrointestinal disorders | Pazopanib | 39 | 240 |
1 to 10 of 332Source ClinicalTrials.gov
See all 332 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pazopanib | ||
| Total, other adverse events | Placebo | 108 | 123 |
| Total, other adverse events | Pazopanib | 232 | 240 |
| Total, serious adverse events | Placebo | 29 | 123 |
| Total, serious adverse events | Pazopanib | 99 | 240 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pazopanib vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00753688
GET https://conductscience.org/api/trials/v1/NCT00753688/results?page=2