Trial · NCT01623869
Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery
NCT01623869, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery. Trials, record NCT01623869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01623869
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery
- NCT number
- NCT01623869
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Angiosarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
- Interventions
- Laboratory Biomarker Analysis, Trebananib
- First posted
- 2012-06-20
- Last updated
- 2015-10-19
- Results first posted
- 2015-07-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Response Rate (CR or PR) Using RECIST | Up to 18 months | Response and progression will be evaluated using the international RECIST guidelines (v1.1). Patients are evaluated every 8 weeks for disease status, with a subsequent 4 week assessment required to confirm a response. Complete Response (CR) - All of the following must be true: 1. Disappearance of all target and non-target lesions, 2. Each target lesion and non-target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): 1. At least a 30% decrease from the baseline measurements of the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. 2. Persistence of one or more non-target lesions or non-target lymph nodes. The confirmed response rate is estimated as the number of patients having a CR or PR, divided by the number of eligible patients having at least one post-baseline assessment. The 95% confidence intervals provided using the method of Duffy and Santner. |
| Secondary | Progression Free Survival (PFS) | From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months | Progression-free survival (PFS) is defined as the duration of time from the start of treatment to time of radiologic or clinical progression or death, whichever occurs first. PFS will be censored at most recent radiographic assessment date for patients remaining alive at the time of the statistical analysis. Kaplan-Meier methodology will be used to estimate the distribution of PFS. |
| Secondary | OS | From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months | Overall survival (OS) is the duration of time from the date of registration/randomization to the date of death or the date of last follow-up for patients who remain alive or who are lost to follow-up at the time of the analysis. Kaplan-Meier methodology will be used to estimate the distribution of OS. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Response Rate (CR or PR) Using RECIST | Up to 18 months | percentage of participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months | months | MEDIAN | |
| SECONDARY | OS | From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months | months | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Response Rate (CR or PR) Using RECIST | Treatment (Trebananib) | 0 | 95% Confidence Interval 0 to 20.6 | percentage of participants | |
| Progression Free Survival (PFS) | Treatment (Trebananib) | 1.6 | 95% Confidence Interval 1.4 to 1.7 | months | |
| OS | Treatment (Trebananib) | 6.4 | 95% Confidence Interval 4.0 to 11.1 | months |
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 (Trebananib) | 16 | |
| Overall Study | COMPLETED | Treatment (Trebananib) | 16 | |
| Overall Study | NOT COMPLETED | Treatment (Trebananib) | 0 |
Source ClinicalTrials.gov
Adverse events56
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 | Anemia | Blood and lymphatic system disorders | Treatment (Trebananib) | 3 | 16 | 4 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Trebananib) | 1 | 16 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Trebananib) | 2 | 16 | 2 |
| other | Edema face | General disorders | Treatment (Trebananib) | 2 | 16 | 6 |
| other | Edema limbs | General disorders | Treatment (Trebananib) | 7 | 16 | 19 |
| other | Fatigue | General disorders | Treatment (Trebananib) | 3 | 16 | 3 |
| other | Pain | General disorders | Treatment (Trebananib) | 1 | 16 | 1 |
| other | Allergic reaction | Immune system disorders | Treatment (Trebananib) | 1 | 16 | 1 |
| other | Infections and infestations - Other, specify | Infections and infestations | Treatment (Trebananib) | 1 | 16 | 1 |
| other | Urinary tract infection | Infections and infestations | Treatment (Trebananib) | 1 | 16 | 1 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Trebananib) | ||
| Total, other adverse events | Treatment (Trebananib) | 12 | 16 |
| Total, serious adverse events | Treatment (Trebananib) | 6 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | 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/NCT01623869
GET https://conductscience.org/api/trials/v1/NCT01623869/events?page=2