Trial · NCT01609790
Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors
NCT01609790, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors. Trials, record NCT01609790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01609790
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors
- NCT number
- NCT01609790
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma, Oligodendroglioma, Recurrent Brain Neoplasm, Recurrent Glioblastoma
- Interventions
- Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study, Placebo Administration, Trebananib
- First posted
- 2012-06-01
- Last updated
- 2022-07-21
- Results first posted
- 2017-02-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1) | From start of treatment to 4 weeks. | Dose-limiting toxicity (DLT), defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity possibly related to protocol treatment during first 4 weeks: grade 4 hematologic toxicity, grade 3/4 thrombocytopenia, or grade 3/4 non-hematologic toxicity; Gastrointestinal fistula, bowel perforation, intracranial hemorrhage, wound dehiscence, or reversible posterior leukoencephalopathy of any grade; Delay of treatment \> 28 days. If 2+ of patients experience a DLT among 6 eligible patients, this drug combination will be considered unsafe and a lower dose of AMG will be explored; otherwise conclude that this drug combination is safe. The probability of claiming safe dose is no more than 16% when the true DLT rate is \>45%, and the probability of claiming safe dose is at least 78% when the true DLT rate is \<= 15%. |
| Primary | Six-month Progression-free Survival (Cohort 2) | From randomization to six months. | As determined by central review of MRI exams, assessed using RANO criteria for progression that is defined by any of the following: \> 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events; Any new lesion; Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose; Failure to return for evaluation due to death or deteriorating condition; Clear progression of non-measurable disease. |
| Secondary | Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2) | From start of treatment up to 3 years. | Adverse events (AEs) are graded by using CTCAE 4.0. Possibly/probably/definitely related to protocol treatment AEs are considered. |
| Secondary | Overall Survival (Cohort 2) | From randomization up to 3 years. | Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months. |
| Secondary | Progression-free Survival (Cohort 2) | From randomization up to 3 years. | Progression-free survival time is measured from randomization to the date of first progression or death or, otherwise, the last follow-up date on which the patient was reported alive. This analysis was planned to occur when all patients had been potentially followed for at least 6 months. |
| Secondary | Radiographic Response Rate (Cohort 2) | From randomization up to 3 years. | Proportion of patients with best overall response of complete response (CR) or partial response (PR) recorded from the start of the treatment until disease progression/recurrence. Response determined by site-reported radiology review of MRI exams using Response Assessment in Neuro-Oncology Criteria (RANO) criteria. CR: Complete disappearance of all enhancing measurable disease (MD) + non-measurable disease (NMD) sustained \>= 4 wks; No new lesions; Stable or improved non-enhancing (T2/FLAIR) lesions; Off corticosteroids (or on physiologic replacement doses only); Stable/improved clinically. PR: \>= 50% decrease vs. baseline of sum of products of perpendicular diameters of all measurable enhancing lesions sustained \>= 4 wks; No progression of NMD; No new lesions; Stable/improved non-enhancing (T2/FLAIR) lesions on \<= dose of corticosteroids vs. baseline scan; Corticosteroid dose at evaluation scan \<= baseline scan dose; Stable or improved clinically. NMD only cannot be a CR or PR. |
| Secondary | Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1) | From randomization up to 3 years. | Feasibility of trebananib weekly in combination with bevacizumab every 2 weeks, measured by the percentage of patients requiring dose reduction/interruption or discontinuation in the first 2 and subsequent courses (Cohort 1) |
| Other | Tumor Genotype, Expression Profile, and Circulating Angiogenesis Biomarkers (Cohort 2) | From randomization to date of death or last followup. Statistical analysis occurs when tumor genotype, expression profile and circulating angiogenesis biomarkers have been determined from the tissue specimens. | Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1) | From start of treatment to 4 weeks. | All eligible patients who started study treatment | participants | NUMBER |
| PRIMARY | Six-month Progression-free Survival (Cohort 2) | From randomization to six months. | Randomized patients evaluable for 6 months progression-free survival (PFS). | percentage of participants | NUMBER |
| SECONDARY | Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2) | From start of treatment up to 3 years. | Randomized and eligible patients who started protocol treatment. | participants | NUMBER |
| SECONDARY | Overall Survival (Cohort 2) | From randomization up to 3 years. | All randomized and eligible patients. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (Cohort 2) | From randomization up to 3 years. | All randomized and eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Radiographic Response Rate (Cohort 2) | From randomization up to 3 years. | All randomized and eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1) | From randomization up to 3 years. | Eligible patients | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Tumor Genotype, Expression Profile, and Circulating Angiogenesis Biomarkers (Cohort 2) | From randomization to date of death or last followup. Statistical analysis occurs when tumor genotype, expression profile and circulating angiogenesis biomarkers have been determined from the tissue specimens. |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1) | Safety Run-In | 0 | participants | ||
| Six-month Progression-free Survival (Cohort 2) | Cohort 2: Bevacizumab+Placebo | 41.1 | 95% Confidence Interval 28.2 to 54.0 | percentage of participants | |
| Six-month Progression-free Survival (Cohort 2) | Cohort 2: Bevacizumab+AMG 386 | 22.6 | 95% Confidence Interval 11.4 to 33.9 | percentage of participants | |
| Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2) | Cohort 2: Bevacizumab+Placebo | 21 | participants | ||
| Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2) | Cohort 2: Bevacizumab+AMG 386 | 20 | participants | ||
| Overall Survival (Cohort 2) | Cohort 2: Bevacizumab+Placebo | 11.5 | 95% Confidence Interval 8.4 to 14.2 | Months | |
| Overall Survival (Cohort 2) | Cohort 2: Bevacizumab+AMG 386 | 7.5 | 95% Confidence Interval 6.8 to 10.1 | Months | |
| Progression-free Survival (Cohort 2) | Cohort 2: Bevacizumab+Placebo | 4.8 | 95% Confidence Interval 3.8 to 7.1 | percentage of participants | |
| Progression-free Survival (Cohort 2) | Cohort 2: Bevacizumab+AMG 386 | 4.2 | 95% Confidence Interval 3.7 to 5.6 | percentage of participants | |
| Radiographic Response Rate (Cohort 2) | Cohort 2: Bevacizumab+Placebo | 5.9 | 95% Confidence Interval 0 to 12.3 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Safety Run-In | 7 | |
| Overall Study | STARTED | Cohort 2: Bevacizumab+Placebo | 65 | |
| Overall Study | STARTED | Cohort 2: Bevacizumab+AMG 386 | 65 | |
| Overall Study | COMPLETED | Cohort 1: Safety Run-In | 6 | |
| Overall Study | COMPLETED | Cohort 2: Bevacizumab+Placebo | 58 | |
| Overall Study | COMPLETED | Cohort 2: Bevacizumab+AMG 386 | 57 | |
| Overall Study | NOT COMPLETED | Cohort 1: Safety Run-In | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2: Bevacizumab+Placebo | 7 | |
| Overall Study | NOT COMPLETED | Cohort 2: Bevacizumab+AMG 386 | 8 |
Source ClinicalTrials.gov
Adverse events552
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 | Cohort 1: Safety Run-In | 3 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2: Bevacizumab+Placebo | 14 | 57 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2: Bevacizumab+AMG 386 | 9 | 57 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 1: Safety Run-In | 1 | 6 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 2: Bevacizumab+Placebo | 1 | 57 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 2: Bevacizumab+AMG 386 | 0 | 57 | |
| other | Hearing impaired | Ear and labyrinth disorders | Cohort 1: Safety Run-In | 1 | 6 | |
| other | Hearing impaired | Ear and labyrinth disorders | Cohort 2: Bevacizumab+Placebo | 0 | 57 | |
| other | Hearing impaired | Ear and labyrinth disorders | Cohort 2: Bevacizumab+AMG 386 | 2 | 57 | |
| other | Cushingoid | Endocrine disorders | Cohort 1: Safety Run-In | 1 | 6 |
1 to 10 of 552Source ClinicalTrials.gov
See all 552 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Safety Run-In | ||
| Total, all-cause mortality | Cohort 2: Bevacizumab+Placebo | ||
| Total, all-cause mortality | Cohort 2: Bevacizumab+AMG 386 | ||
| Total, other adverse events | Cohort 1: Safety Run-In | 6 | 6 |
| Total, other adverse events | Cohort 2: Bevacizumab+Placebo | 57 | 57 |
| Total, other adverse events | Cohort 2: Bevacizumab+AMG 386 | 54 | 57 |
| Total, serious adverse events | Cohort 1: Safety Run-In | 5 | 6 |
| Total, serious adverse events | Cohort 2: Bevacizumab+Placebo | 22 | 57 |
| Total, serious adverse events | Cohort 2: Bevacizumab+AMG 386 | 20 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32154928 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021661 | Radiation Therapy Oncology Group | CURRAN, WALTER J. | AMERICAN COLLEGE OF RADIOLOGY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort 2: Bevacizumab+Placebo vs Cohort 2: Bevacizumab+AMG 386: Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2) |
Source 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/NCT01609790
GET https://conductscience.org/api/trials/v1/NCT01609790/events?page=2