Trial · NCT02330562
Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab
NCT02330562, Phase 1, Phase 2, Completed, Celgene; results first posted 2022-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab. Trials, record NCT02330562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02330562
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab
- NCT number
- NCT02330562
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Malignant Glioma, Glioblastoma
- Interventions
- MRZ, BEV
- First posted
- 2015-01-05
- Last updated
- 2022-06-08
- Results first posted
- 2022-06-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic Objective Response Rate (ORR) - Part 2 Cohort | From first dose to end of study treatment (up to approx. 48 weeks) | Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by the investigator, according to RANO 2010 criteria. Tumor response assessment was conducted every 2 cycles of study therapy. 95% confidence interval from exact binomial distribution (Clopper-Pearson method). |
| Primary | Overall Survival (OS) - Part 3 Cohorts | From first dose to death, assessed up approx. 42 weeks | OS is defined as time from the date of the first dose of study drug to date of death due to any cause. Participants who are alive will be censored at the last follow up visit |
| Secondary | Number of Participants Experiencing Adverse Events | From first dose to 28 days following last dose (up to approx. 72 weeks for Part 1, approx. 52 weeks for Part 2, approx. 46 weeks for Part 3, and approx. 37 weeks for Part 4) | Number of subjects experiencing at least 1 Treatment-Emergent Adverse Event (TEAE) within the timeframe specified. For Part 4, data are presented separately for Cycle 1 (when Marizomib was enterally-administered) and for Cycles 2 and subsequent cycles (when Marizomib was administered IV) |
| Secondary | Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 28 days following last dose (up to approx. 72 weeks for Part 1, approx. 52 weeks for Part 2, approx. 46 weeks for Part 3, and approx. 37 weeks for Part 4) | Number of subjects experiencing at least 1 Serious Adverse Event (SAE) within the timeframe specified. For Part 4, data are presented separately for Cycle 1 (when Marizomib was enterally-administered) and for Cycles 2 and subsequent cycles (when Marizomib was administered IV) |
| Secondary | Number of Participants Experiencing Dose-Limiting Toxicity (DLT) | From first dose to 28 days first dose (during Cycle 1 of study treatment) | Number of subjects experiencing at least 1 DLT event within the timeframe specified. DLT is defined as the occurrence of any of the following AEs related to one of the drugs or the combination observed during Cycle 1, using NCI-CTCAE (v 4.03): * ≥ Grade 3 thrombocytopenia or Grade 2 thrombocytopenia with bleeding. * Grade 4 neutropenia or anemia lasting for more than 4 days. * Febrile neutropenia. * Any ≥ Grade 2 neurological event lasting more than 4 days. * Grade 3 or 4 non-hematologic toxicity (excluding alopecia), lasting for more than 4 days despite adequate supportive therapy or preventing the next scheduled dose from being administered within 4 days of scheduled day; for ≥ Grade 3 fatigue to be considered a DLT, it must be present for more than 7 days. For Part 4, data are presented separately for Cycle 1 (when Marizomib was enterally-administered) and for Cycles 2 and subsequent cycles (when Marizomib was administered IV). DLT was assessed only for Part 1 and Part 4 cohorts. |
| Secondary | Number of Participants Experiencing Dose-Limiting Adverse Events (DLAEs) | From first dose to 28 days following last dose (up to approx. 46 weeks) | Number of subjects experiencing at least 1 DLAE within the timeframe specified. DLAEs are defined as Marizomib-related AEs observed which are: * related to disturbances in the cerebellum (ie, ataxia, dizziness, dysarthria, fall, gait disturbances) plus hallucinations of any grade * any other AEs of Grade ≥ 2. DLAEs were assessed only for Part 3 cohorts. |
| Secondary | Radiographic Objective Response Rate (ORR) | From first dose to end of study treatment (up to approx. 68 weeks for Part 1, and approx. 42 weeks for Part 3) | Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by the investigator, according to RANO 2010 criteria. Tumor response assessment was conducted every 2 cycles of study therapy. 95% confidence interval from exact binomial distribution (Clopper-Pearson method). Radiographic ORR was assessed for Part 1 and Part 3 cohorts |
| Secondary | Progression Free Survival (PFS) | From first dose to disease progression or death, assessed up to approx. 68 weeks for Part 1, approx. 48 weeks for Part 2, approx. 42 weeks for Part 3, and approx. 33 weeks for Part 4 | PFS is defined as the time between start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurs first. Disease progression will be determined using RANO 2010 criteria as assessed by the investigator. PFS was determined using Kaplan-Meier product-limit estimates. |
| Secondary | Overall Survival (OS) | From first dose to death, assessed up to approx. 68 weeks for Part 1, approx. 48 weeks for Part 2, and approx. 33 weeks for Part 4 | OS is defined as time from the date of the first dose of study drug to date of death due to any cause. Participants who are alive will be censored at the last follow up visit |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radiographic Objective Response Rate (ORR) - Part 2 Cohort | From first dose to end of study treatment (up to approx. 48 weeks) | All treated participants in Part 2 Cohort | Percent of participants | NUMBER |
| PRIMARY | Overall Survival (OS) - Part 3 Cohorts | From first dose to death, assessed up approx. 42 weeks | All treated participants in Part 3 | Months | MEDIAN |
| SECONDARY | Number of Participants Experiencing Adverse Events | From first dose to 28 days following last dose (up to approx. 72 weeks for Part 1, approx. 52 weeks for Part 2, approx. 46 weeks for Part 3, and approx. 37 weeks for Part 4) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 28 days following last dose (up to approx. 72 weeks for Part 1, approx. 52 weeks for Part 2, approx. 46 weeks for Part 3, and approx. 37 weeks for Part 4) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Dose-Limiting Toxicity (DLT) | From first dose to 28 days first dose (during Cycle 1 of study treatment) | All treated participants in Part 1 and Part 4 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Dose-Limiting Adverse Events (DLAEs) | From first dose to 28 days following last dose (up to approx. 46 weeks) | All treated participants in Part 3 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Radiographic Objective Response Rate (ORR) | From first dose to end of study treatment (up to approx. 68 weeks for Part 1, and approx. 42 weeks for Part 3) | All treated participants with available measurements | Percent of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From first dose to disease progression or death, assessed up to approx. 68 weeks for Part 1, approx. 48 weeks for Part 2, approx. 42 weeks for Part 3, and approx. 33 weeks for Part 4 | All treated participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From first dose to death, assessed up to approx. 68 weeks for Part 1, approx. 48 weeks for Part 2, and approx. 33 weeks for Part 4 | All treated participants | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Radiographic Objective Response Rate (ORR) - Part 2 Cohort | Part 2 Cohort | 3.3 | 95% Confidence Interval 0.1 to 17.2 | Percent of participants | |
| Overall Survival (OS) - Part 3 Cohorts | Part 3 Cohort 1 | 8.3 | 95% Confidence Interval 4.8 to 11.3 | Months | |
| Overall Survival (OS) - Part 3 Cohorts | Part 3 Cohort 2 | 7.5 | 95% Confidence Interval 3.5 to 12.9 | Months | |
| Number of Participants Experiencing Adverse Events | Part 1 Cohort 1 | 6 | Participants | ||
| Number of Participants Experiencing Adverse Events | Part 1 Cohort 2 | 3 | Participants | ||
| Number of Participants Experiencing Adverse Events | Part 1 MTD + Dose Expansion Cohort | 27 | Participants | ||
| Number of Participants Experiencing Adverse Events | Part 2 Cohort | 30 | Participants | ||
| Number of Participants Experiencing Adverse Events | Part 3 Cohort 1 | 31 | Participants | ||
| Number of Participants Experiencing Adverse Events | Part 3 Cohort 2 | 10 | Participants | ||
| Number of Participants Experiencing Adverse Events | Part 4 Cohort 1 - Cycle 1 | 1 | Participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 Cohort 1 | 6 | |
| Overall Study | STARTED | Part 1 Cohort 2 | 3 | |
| Overall Study | STARTED | Part 1 MTD + Dose Expansion Cohort | 27 | |
| Overall Study | STARTED | Part 2 Cohort | 30 | |
| Overall Study | STARTED | Part 3 Cohort 1 | 31 | |
| Overall Study | STARTED | Part 3 Cohort 2 | 10 | |
| Overall Study | STARTED | Part 4 Cohort 1 | 1 | |
| Overall Study | STARTED | Part 4 Cohort 2 | 1 | |
| Overall Study | STARTED | Part 4 Cohort 3 | 1 | |
| Overall Study | STARTED | Part 4 Cohort 4 | 5 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events2,629
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 | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 1 | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Cohort 2 | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 MTD + Dose Expansion Cohort | 6 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 Cohort | 6 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 3 Cohort 1 | 4 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 3 Cohort 2 | 2 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 4 Cohort 1 | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 4 Cohort 2 | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 4 Cohort 3 | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 4 Cohort 4 | 2 | 5 |
1 to 10 of 2,629Source ClinicalTrials.gov
See all 2,629 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Cohort 1 | 5 | 6 |
| Total, all-cause mortality | Part 1 Cohort 2 | 2 | 3 |
| Total, all-cause mortality | Part 1 MTD + Dose Expansion Cohort | 21 | 27 |
| Total, all-cause mortality | Part 2 Cohort | 24 | 30 |
| Total, all-cause mortality | Part 3 Cohort 1 | 25 | 31 |
| Total, all-cause mortality | Part 3 Cohort 2 | 9 | 10 |
| Total, all-cause mortality | Part 4 Cohort 1 | 1 | 1 |
| Total, all-cause mortality | Part 4 Cohort 2 | 0 | 1 |
| Total, all-cause mortality | Part 4 Cohort 3 | 1 | 1 |
| Total, all-cause mortality | Part 4 Cohort 4 | 1 | 5 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Part 3 Cohort 1 vs Part 3 Cohort 2: Number of Participants Experiencing Dose-Limiting Adverse Events (DLAEs) |
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/NCT02330562
GET https://conductscience.org/api/trials/v1/NCT02330562/results?page=2