Trial · NCT02212015
Evaluation of Votrient in Angiosarcoma
NCT02212015, Phase 2, Terminated, Heidelberg University; results first posted 2022-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Votrient in Angiosarcoma. Trials, record NCT02212015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02212015
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Votrient in Angiosarcoma
- NCT number
- NCT02212015
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Heidelberg University
- Conditions
- Angiosarcoma
- Interventions
- Pazopanib + Paclitaxel
- First posted
- 2014-08-08
- Last updated
- 2022-03-22
- Results first posted
- 2022-03-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Progression-free Survival | 6 Month | The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions. |
| Primary | Rate of Progression-free Survival, Subgroup 1 Analysis | 6 months | Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into cutaneous angiosarcoma versus visceral angiosarcoma The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions. |
| Primary | Rate of Progression-free Survival, Subgroup 2 Analysis | 6 months | Rate of progression-free survival for Subgroup 1 categorizing the 12 participants who showed PFS after 6 months into primary angiosarcoma versus secondary angiosarcoma. The diagnosis of progession is based on tumor measurements assessed 182 days +/- 32 days after start of treatment (with imaging date as reference date) and according to the RECIST Version 1.1 criteria based on a predefined set of target lesions and non-target lesions. |
| Secondary | Overall Survival | from start of treatment until death within study's actual observation time for OS (22 months). | Survival time of patient from start of treatment until death |
| Secondary | Overall Survival, Subgroup 1 Analysis | from start of treatment until death within study's actual observation time for OS (22 months) | Survival time of patients from start of treatment until death, Subgroup 1 categorizing 26 overall participants into 18 cutaneous angiosarcoma versus 8 visceral angiosarcomas |
| Secondary | Overall Survival, Subgroup 2 Analysis | from start of treatment until death within study's actual observation time for OS (22 months) | Survival time of patients from start of treatment until death, Subgroup 2 categorizing 26 overall participants into 13 primary cutaneous angiosarcoma versus 13 secondary angiosarcomas |
| Secondary | Response Rate (RR) | determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR | Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies |
| Secondary | Response Rate (RR), Subgroup1 Analysis | determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR | Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 1 which is the analysis of cutaneous angiosarcoma versus visceral angiosarcoma |
| Secondary | Response Rate (RR), Subgroup 2 Analysis | determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR | Measurable skin lesions will be evaluated clinically and documented photographically, all other target lesions will be evaluated radiologically by CT or MRI according to RECIST Version 1.1. RR is given as 'Best overall response" BOR" defined as CR (complete remission), PR (partial) remission), SD (stable diesease) and PD (progressive disease) or NE (not evaluated) and provided by absolute and relative frequencies for Subgroup 2 which is the analysis of primary angiosarcoma versus secondary angiosarcoma |
| Secondary | Adverse Events and Serious Adverse Events | 30 days after EOS of last patient or end of overall study observation period (22 months) | Number of patients in which adverse events occur during treatment according to Common Toxicity Criteria for Adverse Effects, Version 4.0 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Progression-free Survival | 6 Month | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Rate of Progression-free Survival, Subgroup 1 Analysis | 6 months | Subgroup 1 (categorizing total number of 12 participants showing PFR survival after 6 months into cutaneous AS versus visceral AS) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Rate of Progression-free Survival, Subgroup 2 Analysis | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | from start of treatment until death within study's actual observation time for OS (22 months). | months | MEDIAN | |
| SECONDARY | Overall Survival, Subgroup 1 Analysis | from start of treatment until death within study's actual observation time for OS (22 months) | Overall number of participants analyzed is 26. Thereof, 18 show cutaneous angiosarcoma, and 8 show cutaneos angiosarcoma. | months | MEDIAN |
| SECONDARY | Overall Survival, Subgroup 2 Analysis | from start of treatment until death within study's actual observation time for OS (22 months) | Overall number of participants analyzed is 26. Thereof, 13 show cutaneous angiosarcoma, and 13 show cutaneos angiosarcoma | months | MEDIAN |
| SECONDARY | Response Rate (RR) | determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Response Rate (RR), Subgroup1 Analysis | determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR | Total number of participants analyzed is 26. Thereof, 18 show cutaneous AS, and 8 show visceral angiosarcoma | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Rate (RR), Subgroup 2 Analysis | determined every 8 weeks during first 6 month then every 12 weeks in follow-up period until progression or death or end of overall study observation period (22 months), then evaluated as BOR | Total number of participants analyzed is 26. Thereof, 13 show primary angiosarcoma, and 13 show secondary angiosarcoma | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adverse Events and Serious Adverse Events | 30 days after EOS of last patient or end of overall study observation period (22 months) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Progression-free Survival | Pazopanib + Paclitaxel | 12 | Participants | ||
| Rate of Progression-free Survival, Subgroup 1 Analysis | Pazopanib + Paclitaxel | cutaneous angiosarcoma | 11 | Participants | |
| Rate of Progression-free Survival, Subgroup 1 Analysis | Pazopanib + Paclitaxel | visceral angiosarcoma | 1 | Participants | |
| Rate of Progression-free Survival, Subgroup 2 Analysis | Pazopanib + Paclitaxel | primary angiosarcoma | 6 | Participants | |
| Rate of Progression-free Survival, Subgroup 2 Analysis | Pazopanib + Paclitaxel | secondary angiosarcoma | 6 | Participants | |
| Overall Survival | Pazopanib + Paclitaxel | 21.6 | 95% Confidence Interval 20.5 to NA | months | |
| Overall Survival, Subgroup 1 Analysis | Pazopanib + Paclitaxel | cutaneous angiosarcoma | 21.6 | 95% Confidence Interval 10.0 to 21.6 | months |
| Overall Survival, Subgroup 1 Analysis | Pazopanib + Paclitaxel | visceral angiosaroma | 20.5 | 95% Confidence Interval 2.8 to NA | months |
| Overall Survival, Subgroup 2 Analysis | Pazopanib + Paclitaxel | primary angiosarcoma | 20.5 | 95% Confidence Interval 10.0 to NA | months |
| Overall Survival, Subgroup 2 Analysis | Pazopanib + Paclitaxel | secondary angiosarcoma | 21.6 | 95% Confidence Interval NA to NA | months |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib + Paclitaxel | 26 | |
| Overall Study | COMPLETED | Pazopanib + Paclitaxel | 25 | |
| Overall Study | NOT COMPLETED | Pazopanib + Paclitaxel | 1 |
Source ClinicalTrials.gov
Adverse events59
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 | ALT increased | Hepatobiliary disorders | Pazopanib + Paclitaxel | 4 | 26 | 12 |
| other | AST increased | Hepatobiliary disorders | Pazopanib + Paclitaxel | 4 | 26 | 12 |
| other | Allergic reation to a drug | Product Issues | Pazopanib + Paclitaxel | 2 | 26 | 2 |
| other | Reduced general condition | General disorders | Pazopanib + Paclitaxel | 2 | 26 | 2 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pazopanib + Paclitaxel | 8 | 26 | 9 |
| other | Anemia | Blood and lymphatic system disorders | Pazopanib + Paclitaxel | 3 | 26 | 6 |
| other | Inappetance | Musculoskeletal and connective tissue disorders | Pazopanib + Paclitaxel | 4 | 26 | 4 |
| other | Hypertension | Vascular disorders | Pazopanib + Paclitaxel | 12 | 26 | 17 |
| other | Rash | Skin and subcutaneous tissue disorders | Pazopanib + Paclitaxel | 3 | 26 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Pazopanib + Paclitaxel | 5 | 26 | 6 |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib + Paclitaxel | 1 | 26 |
| Total, other adverse events | Pazopanib + Paclitaxel | 25 | 26 |
| Total, serious adverse events | Pazopanib + Paclitaxel | 10 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 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/NCT02212015
GET https://conductscience.org/api/trials/v1/NCT02212015/results?page=2