Trial · NCT01727089
Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
NCT01727089, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer. Trials, record NCT01727089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01727089
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
- NCT number
- NCT01727089
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer, Type 1 Papillary Renal Cell Carcinoma, Type 2 Papillary Renal Cell Carcinoma
- Interventions
- Anti-Endoglin Chimeric Monoclonal Antibody TRC105, Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study
- First posted
- 2012-11-15
- Last updated
- 2018-08-28
- Results first posted
- 2018-06-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival at 24 Weeks | The duration of time from start of treatment to time of progression or death, assessed at 24 weeks | Progression-free survival 24 after starting treatment. 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. |
| Primary | Progression-free Survival at 12 Weeks | The duration of time from start of treatment to time of progression or death, assessed at 12 weeks | Progression-free survival 12 after starting treatment. 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. |
| Secondary | Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment | From time of treatment initiation until 30 days post treatment, assessed every 4 weeks. | The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be utilized for AE reporting. Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related adverse event. |
| Secondary | Number of Participants With Overall Response | From time of treatment initiation until conclusion of treatment, assessed every 12 weeks. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival at 24 Weeks | The duration of time from start of treatment to time of progression or death, assessed at 24 weeks | percentage of participants | NUMBER | |
| PRIMARY | Progression-free Survival at 12 Weeks | The duration of time from start of treatment to time of progression or death, assessed at 12 weeks | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment | From time of treatment initiation until 30 days post treatment, assessed every 4 weeks. | participants | NUMBER | |
| SECONDARY | Number of Participants With Overall Response | From time of treatment initiation until conclusion of treatment, assessed every 12 weeks. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival at 24 Weeks | Arm I (Bevacizumab) | 52 | 95% Confidence Interval 36 to 76 | percentage of participants | |
| Progression-free Survival at 24 Weeks | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 27 | 95% Confidence Interval 15 to 50 | percentage of participants | |
| Progression-free Survival at 12 Weeks | Arm I (Bevacizumab) | 66 | 95% Confidence Interval 51 to 86 | percentage of participants | |
| Progression-free Survival at 12 Weeks | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 58 | 95% Confidence Interval 42 to 71 | percentage of participants | |
| Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment | Arm I (Bevacizumab) | Abdominal pain | 3 | participants | |
| Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | Abdominal pain | 3 | participants | |
| Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment | Arm I (Bevacizumab) | Anemia | 4 | participants | |
| Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | Anemia | 8 | participants | |
| Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment | Arm I (Bevacizumab) | Anorexia | 0 | participants | |
| Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | Anorexia | 1 | participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Bevacizumab) | 29 | |
| Overall Study | STARTED | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 30 | |
| Overall Study | COMPLETED | Arm I (Bevacizumab) | 29 | |
| Overall Study | COMPLETED | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 30 | |
| Overall Study | NOT COMPLETED | Arm I (Bevacizumab) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 0 |
Source ClinicalTrials.gov
Adverse events530
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 | Arm I (Bevacizumab) | 10 | 29 | 29 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 16 | 30 | 79 |
| other | Sinus bradycardia | Cardiac disorders | Arm I (Bevacizumab) | 3 | 29 | 11 |
| other | Sinus bradycardia | Cardiac disorders | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 5 | 30 | 9 |
| other | Sinus tachycardia | Cardiac disorders | Arm I (Bevacizumab) | 1 | 29 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 5 | 30 | 13 |
| other | Ear pain | Ear and labyrinth disorders | Arm I (Bevacizumab) | 1 | 29 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 0 | 30 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Arm I (Bevacizumab) | 2 | 29 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 0 | 30 | 0 |
1 to 10 of 530Source ClinicalTrials.gov
See all 530 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Bevacizumab) | 4 | 29 |
| Total, all-cause mortality | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 5 | 30 |
| Total, other adverse events | Arm I (Bevacizumab) | 29 | 29 |
| Total, other adverse events | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 29 | 30 |
| Total, serious adverse events | Arm I (Bevacizumab) | 10 | 29 |
| Total, serious adverse events | Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105) | 14 | 30 |
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 |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Bevacizumab) vs Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105): Number of Participants With Overall Response | Trial comparisons |
| Arm I (Bevacizumab) vs Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105): deaths from any cause | Trial comparisons |
| Arm I (Bevacizumab) vs Arm II (Bevacizumab, Anti-endoglin Monoclonal Antibody TRC105): 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/NCT01727089
GET https://conductscience.org/api/trials/v1/NCT01727089/results?page=2