Trial · NCT01462630
Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma
NCT01462630, Phase 2, Completed, Fox Chase Cancer Center; results first posted 2022-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma. Trials, record NCT01462630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01462630
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma
- NCT number
- NCT01462630
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Fox Chase Cancer Center
- Conditions
- Adult Angiosarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
- Interventions
- pazopanib hydrochloride, laboratory biomarker analysis, positron emission tomography, computed tomography, fludeoxyglucose F 18
- First posted
- 2011-10-31
- Last updated
- 2022-08-19
- Results first posted
- 2022-08-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS Rate | 3 months | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was estimated using the method of Kaplan and Meier. |
| Primary | Response Rate Defined as CR | 3 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates. |
| Primary | Response Rate Defined as Partial Response (PR) | 3 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Standard estimates of the binomial proportion will be used to estimate and place confidence bounds on the several response rates. |
| Secondary | Overall Survival of Patients Treated With Pazopanib Hydrochloride | Up to 107 weeks | Estimated using the method of Kaplan and Meier. |
| Secondary | Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population | Up to 2 years | Toxicities related/unrelated to study treatment with \>10% frequency |
| Secondary | Ability of [F-18] FDG PET/CT as an Imaging Agent in Predicting Efficacy or Early Response as Compared With CT Imaging | Up to 2 years | Descriptive statistics will include mean, SD, median, minimum, and maximum for continuous variables and the numbers and percentages for categorical variables. Summary statistics for changes in SUVs, tumor to background ratios, lesion size, and comparison scores will be analyzed and presented. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PFS Rate | 3 months | Of the 26 patients who started therapy, response was not evaluable in 8 patients due to lab abnormalities at C1D1 (n=1), consent withdrawal (n=2), toxicity (n=4), and non-compliance (n=1) | percentage of patients | NUMBER |
| PRIMARY | Response Rate Defined as CR | 3 months | 7 of 29 patients were not evaluable for response | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Response Rate Defined as Partial Response (PR) | 3 months | 7 of 29 patients were not evaluable for response | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival of Patients Treated With Pazopanib Hydrochloride | Up to 107 weeks | weeks | MEDIAN | |
| SECONDARY | Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population | Up to 2 years | All patients initially enrolled were followed for toxicities | toxicities | NUMBER |
| SECONDARY | Ability of [F-18] FDG PET/CT as an Imaging Agent in Predicting Efficacy or Early Response as Compared With CT Imaging | Up to 2 years | No data collected for comparison |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PFS Rate | Treatment (Enzyme Inhibitor Therapy) | 54.6 | 95% Confidence Interval 36.0 to 82.9 | percentage of patients | |
| Response Rate Defined as CR | Treatment (Enzyme Inhibitor Therapy) | 0 | Participants | ||
| Response Rate Defined as Partial Response (PR) | Treatment (Enzyme Inhibitor Therapy) | 1 | Participants | ||
| Overall Survival of Patients Treated With Pazopanib Hydrochloride | Treatment (Enzyme Inhibitor Therapy) | 69.8 | 95% Confidence Interval 42.3 to 106.7 | weeks | |
| Evaluation of Toxicity of Pazopanib Hydrochloride in This Patient Population | Treatment (Enzyme Inhibitor Therapy) | 189 | toxicities |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Enzyme Inhibitor Therapy) | 29 | |
| Overall Study | COMPLETED | Treatment (Enzyme Inhibitor Therapy) | 22 | |
| Overall Study | NOT COMPLETED | Treatment (Enzyme Inhibitor Therapy) | 7 |
Source ClinicalTrials.gov
Adverse events78
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 | Rhinitis | Infections and infestations | Treatment (Enzyme Inhibitor Therapy) | 1 | 29 | |
| other | Low hemoglobin | Blood and lymphatic system disorders | Treatment (Enzyme Inhibitor Therapy) | 9 | 29 | |
| other | Low absolute neutrophil count | Blood and lymphatic system disorders | Treatment (Enzyme Inhibitor Therapy) | 3 | 29 | |
| other | Low white blood cell count | Investigations | Treatment (Enzyme Inhibitor Therapy) | 7 | 29 | |
| other | Lymphocyte count decrease | Investigations | Treatment (Enzyme Inhibitor Therapy) | 4 | 29 | |
| other | Edema | General disorders | Treatment (Enzyme Inhibitor Therapy) | 3 | 29 | |
| other | Hypertension | Vascular disorders | Treatment (Enzyme Inhibitor Therapy) | 14 | 29 | |
| other | Ortho-hypotension | Vascular disorders | Treatment (Enzyme Inhibitor Therapy) | 2 | 29 | |
| other | Palpitation | Cardiac disorders | Treatment (Enzyme Inhibitor Therapy) | 1 | 29 | |
| other | Dizzeness | Nervous system disorders | Treatment (Enzyme Inhibitor Therapy) | 8 | 29 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Enzyme Inhibitor Therapy) | 1 | 29 |
| Total, other adverse events | Treatment (Enzyme Inhibitor Therapy) | 29 | 29 |
| Total, serious adverse events | Treatment (Enzyme Inhibitor Therapy) | 13 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA006927 | Comprehensive Cancer Center Program at Fox Chase | WIEST, DAVID L. | RESEARCH INST OF FOX CHASE CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01462630
GET https://conductscience.org/api/trials/v1/NCT01462630/events?page=2