Trial · NCT01055028
Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma
NCT01055028, Phase 2, Terminated, Stanford University; results first posted 2018-03-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma. Trials, record NCT01055028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01055028
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma
- NCT number
- NCT01055028
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Angiosarcomas, Soft Tissue Sarcoma
- Interventions
- Bevacizumab, Paclitaxel
- First posted
- 2010-01-25
- Last updated
- 2018-03-26
- Results first posted
- 2018-03-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 4 months | The primary objective of this study was to evaluate progression-free survival (PFS or non-progression rate) through 4 months from start of treatment. Progression is defined as ≥ 20% increase in the sum of the longest diameter of target lesions, as compared to the baseline measurements, and/or the appearance of one or more new lesion(s). |
| Secondary | Overall Response Rate After 3 Cycles | 12 weeks | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 3 cycles of treatment (12 weeks) is expressed as the number and proportion of subjects. RECIST Criteria * CR = Disappearance of all target lesions * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s), * Stable disease (SD) = Small changes that do not meet any of the above criteria |
| Secondary | Overall Response Rate After 6th Cycle | 6 Cycles | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 6 cycles of treatment (24 weeks) is expressed as the number and proportion of subjects. RECIST Criteria * CR = Disappearance of all target lesions * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s), * Stable disease (SD) = Small changes that do not meet any of the above criteria |
| Secondary | Overall Survival (OS) at 6 Months | 6 months | Assessed as the number of subjects known to remain alive 6 months after study entry |
| Secondary | Overall Survival (OS) at 12 Months | 12 months | Assessed as the number of subjects known to remain alive 12 months after study entry |
Source ClinicalTrials.gov
Outcomes5
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) | 4 months | Includes all subjects that started treatment | Participants without disease progression | NUMBER |
| SECONDARY | Overall Response Rate After 3 Cycles | 12 weeks | Includes participants that complete 3 cycles of treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate After 6th Cycle | 6 Cycles | Includes participants that complete 6 cycles of treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) at 6 Months | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) at 12 Months | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
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) | Regimen A Treatment 1 | 4 | Participants without disease progression | ||
| Progression-free Survival (PFS) | Regimen B Treatment 2 | 5 | Participants without disease progression | ||
| Overall Response Rate After 3 Cycles | Regimen A Treatment 1 | Complete Response (CR) | 1 | Participants | |
| Overall Response Rate After 3 Cycles | Regimen B Treatment 2 | Complete Response (CR) | 0 | Participants | |
| Overall Response Rate After 3 Cycles | Regimen A Treatment 1 | Partial Response (PR) | 2 | Participants | |
| Overall Response Rate After 3 Cycles | Regimen B Treatment 2 | Partial Response (PR) | 2 | Participants | |
| Overall Response Rate After 3 Cycles | Regimen A Treatment 1 | Stable Disease (SD) | 1 | Participants | |
| Overall Response Rate After 3 Cycles | Regimen B Treatment 2 | Stable Disease (SD) | 2 | Participants | |
| Overall Response Rate After 3 Cycles | Regimen A Treatment 1 | Progressive Disease (PD) | 2 | Participants | |
| Overall Response Rate After 3 Cycles | Regimen B Treatment 2 | Progressive Disease (PD) | 1 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening | STARTED | Regimen A Treatment 1 | 9 | |
| Screening | STARTED | Regimen B Treatment 2 | 9 | |
| Screening | COMPLETED | Regimen A Treatment 1 | 8 | |
| Screening | COMPLETED | Regimen B Treatment 2 | 8 | |
| Screening | NOT COMPLETED | Regimen A Treatment 1 | 1 | |
| Screening | NOT COMPLETED | Regimen B Treatment 2 | 1 | |
| Treatment Cycles 1 to 3 | STARTED | Regimen A Treatment 1 | 8 | |
| Treatment Cycles 1 to 3 | STARTED | Regimen B Treatment 2 | 8 | |
| Treatment Cycles 1 to 3 | COMPLETED | Regimen A Treatment 1 | 6 | |
| Treatment Cycles 1 to 3 | COMPLETED | Regimen B Treatment 2 | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events324
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 | Regimen A Treatment 1 | 2 | 8 | 2 |
| other | Nausea | Gastrointestinal disorders | Regimen B Treatment 2 | 1 | 8 | 1 |
| other | Intermittent nausea | Gastrointestinal disorders | Regimen A Treatment 1 | 1 | 8 | 1 |
| other | Intermittent nausea | Gastrointestinal disorders | Regimen B Treatment 2 | 0 | 8 | 0 |
| other | Vomiting | Gastrointestinal disorders | Regimen A Treatment 1 | 2 | 8 | 2 |
| other | Vomiting | Gastrointestinal disorders | Regimen B Treatment 2 | 0 | 8 | 0 |
| other | Intermittent vomiting | Gastrointestinal disorders | Regimen A Treatment 1 | 1 | 8 | 1 |
| other | Intermittent vomiting | Gastrointestinal disorders | Regimen B Treatment 2 | 0 | 8 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Regimen A Treatment 1 | 0 | 8 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Regimen B Treatment 2 | 1 | 8 | 1 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen A Treatment 1 | 0 | 8 |
| Total, all-cause mortality | Regimen B Treatment 2 | 0 | 8 |
| Total, other adverse events | Regimen A Treatment 1 | 8 | 8 |
| Total, other adverse events | Regimen B Treatment 2 | 8 | 8 |
| Total, serious adverse events | Regimen A Treatment 1 | 8 | 8 |
| Total, serious adverse events | Regimen B Treatment 2 | 4 | 8 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Regimen A / Treatment 1 vs Regimen B / Treatment 2: Overall Survival (OS) at 6 Months | Trial comparisons |
| Regimen A / Treatment 1 vs Regimen B / Treatment 2: Overall Survival (OS) at 12 Months | Trial comparisons |
| Regimen A Treatment 1 vs Regimen B Treatment 2: deaths from any cause | Trial comparisons |
| Regimen A Treatment 1 vs Regimen B Treatment 2: serious adverse events | 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/NCT01055028
GET https://conductscience.org/api/trials/v1/NCT01055028/results?page=2