Trial · NCT02152982
Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT02152982, Phase 2, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Trials, record NCT02152982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02152982
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- NCT number
- NCT02152982
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 447 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Glioblastoma, Gliosarcoma
- Interventions
- Laboratory Biomarker Analysis, Placebo Administration, Quality-of-Life Assessment, Temozolomide, Veliparib
- First posted
- 2014-06-02
- Last updated
- 2026-10-27
- Results first posted
- 2023-04-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 83 months | The distribution of OS for each arm will be estimated using the Kaplan-Meier method and compared with a stratified logrank test. |
| Secondary | Interaction With Optune Device | 10 years | Cox proportional hazards model will be used to evaluate whether there is a potential interaction between the treatment arm and the Optune device. If an interaction is detected, separate analyses of treatment effect (using Cox models) will be done for patients treated with the Optune device and patients who were not treated with the Optune device. |
| Secondary | Progression-free Survival (PFS) | 120 months | The distribution of PFS for each arm will be estimated using the Kaplan-Meier method, and be compared using Cox proportional hazard models with all stratification factors adjusted. Progression (PD): Defined by any of the following: 1. \> 25% increase in sum of products of perpendicular diameters of enhancing lesions, compared with the smallest tumor measurement obtained either at baseline or best response 2. Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after therapy initiation (stable doses of steroids include patient not on steroids) not caused by comorbid events 3. Any new lesion 4. Clear clinical deterioration not attributable to other causes apart from tumor or change in corticosteroid dose 5. Failure to return for evaluation as a result of death or deteriorating condition 6. Clear progression of non-measurable disease |
| Secondary | Objective Tumor Response | 5 years | Defined as complete response (CR) or partial response (PR) as specified in the Revised Assessment in Neuro-Oncology (RANO) criteria. An objective tumor response will be evaluated for each patient and the tumor response count will be summarized for each arm and compared using the Chi-square test. For CR, all of the following must be true: disappearance of all enhancing measurable and non-measurable disease; no new enhancing lesions; stable or improved non-enhancing lesions; patients must be off corticosteroids; stable or improved clinically A PR requires all of the following: \> 50% decrease in sum of products of perpendicular diameters of all measurable enhancing lesions compared with baseline; no progression of non-measurable disease; no new lesions; stable or improved non-enhancing lesions on same or lower dose of corticosteroids compared with baseline scan; steroid dose should be same or lower compared with baseline scan; stable or improved clinically |
| Secondary | Overall Adverse Event Rates for Grade 3 or Higher Adverse Events | 5 years | Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5 beginning April 1, 2018). The overall adverse event rates for grade 3 or higher adverse events will be summarized and be compared using Chi-Square or Fisher's Exact tests between treatment arms. The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. Treatment-related adverse events will be tabulated for each arm. |
| Other | Change in Quality of Life (QOL) | Baseline to up to 5 years | Measured by the fatigue/uniscale tool. The fatigue/uniscale tool will be used as a measure of QOL. Potential differences in fatigue levels of patients treated on the two different arms will be evaluated. Changes in this measure will be evaluated over the course of treatment for both arms and will be compared using a two-sample t-test at each timepoint. Will also compute a normalized area under the curve (AUC) for the values of each patient over time and compare the mean AUCs for patients on the two arms. |
| Other | MGMT Status | Baseline | The concordance between site-determined MGMT methylation status and central laboratory determination of MGMT status will be analyzed using the Chi-Square test of proportions and 95% confidence intervals for the proportion of tests in disagreement with the local site. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | 83 months | months | MEDIAN | |
| SECONDARY | Interaction With Optune Device | 10 years | Analysis population is patients that reported actual optune use | participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | 120 months | months | MEDIAN | |
| SECONDARY | Objective Tumor Response | 5 years | All patients randomized to the trial with measurable disease per RANO criteria at registration and at one or more assessment(s) post-baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Adverse Event Rates for Grade 3 or Higher Adverse Events | 5 years | Only includes patients that began treatment | participants with at least 1 grade 3+ AE | NUMBER |
| OTHER_PRE_SPECIFIED | Change in Quality of Life (QOL) | Baseline to up to 5 years | |||
| OTHER_PRE_SPECIFIED | MGMT Status | Baseline |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Arm I (Temozolomide, Placebo) | 24.8 | 90% Confidence Interval 22.6 to 27.7 | months | |
| Overall Survival (OS) | Arm II (Temozolomide, Veliparib) | 28.1 | 90% Confidence Interval 24.3 to 33.3 | months | |
| Interaction With Optune Device | Arm I (Temozolomide, Placebo) | Reporting actual Optune use | 42 | participants | |
| Interaction With Optune Device | Arm II (Temozolomide, Veliparib) | Reporting actual Optune use | 42 | participants | |
| Interaction With Optune Device | Arm I (Temozolomide, Placebo) | No actual Optune use | 182 | participants | |
| Interaction With Optune Device | Arm II (Temozolomide, Veliparib) | No actual Optune use | 181 | participants | |
| Progression-free Survival (PFS) | Arm I (Temozolomide, Placebo) | 12.1 | 95% Confidence Interval 10.6 to 14.9 | months | |
| Progression-free Survival (PFS) | Arm II (Temozolomide, Veliparib) | 13.2 | 95% Confidence Interval 10.5 to 14.9 | months | |
| Objective Tumor Response | Arm I (Temozolomide, Placebo) | 34 | Participants | ||
| Objective Tumor Response | Arm II (Temozolomide, Veliparib) | 37 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Temozolomide, Placebo) | 224 | |
| Overall Study | STARTED | Arm II (Temozolomide, Veliparib) | 223 | |
| Overall Study | Started Treatment | Arm I (Temozolomide, Placebo) | 213 | |
| Overall Study | Started Treatment | Arm II (Temozolomide, Veliparib) | 218 | |
| Overall Study | COMPLETED | Arm I (Temozolomide, Placebo) | 144 | |
| Overall Study | COMPLETED | Arm II (Temozolomide, Veliparib) | 134 | |
| Overall Study | NOT COMPLETED | Arm I (Temozolomide, Placebo) | 80 | |
| Overall Study | NOT COMPLETED | Arm II (Temozolomide, Veliparib) | 89 |
Source ClinicalTrials.gov
Adverse events464
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 (Temozolomide, Placebo) | 17 | 213 | 36 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Temozolomide, Veliparib) | 36 | 218 | 84 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm I (Temozolomide, Placebo) | 1 | 213 | 1 |
| other | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Arm II (Temozolomide, Veliparib) | 0 | 218 | 0 |
| other | Chest pain - cardiac | Cardiac disorders | Arm I (Temozolomide, Placebo) | 1 | 213 | 1 |
| other | Chest pain - cardiac | Cardiac disorders | Arm II (Temozolomide, Veliparib) | 0 | 218 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Arm I (Temozolomide, Placebo) | 1 | 213 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Arm II (Temozolomide, Veliparib) | 1 | 218 | 1 |
| other | Ear and labyrinth disorders - Oth spec | Ear and labyrinth disorders | Arm I (Temozolomide, Placebo) | 0 | 213 | 0 |
| other | Ear and labyrinth disorders - Oth spec | Ear and labyrinth disorders | Arm II (Temozolomide, Veliparib) | 3 | 218 | 4 |
1 to 10 of 464Source ClinicalTrials.gov
See all 464 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Temozolomide, Placebo) | 175 | 213 |
| Total, all-cause mortality | Arm II (Temozolomide, Veliparib) | 183 | 218 |
| Total, other adverse events | Arm I (Temozolomide, Placebo) | 207 | 213 |
| Total, other adverse events | Arm II (Temozolomide, Veliparib) | 217 | 218 |
| Total, serious adverse events | Arm I (Temozolomide, Placebo) | 47 | 213 |
| Total, serious adverse events | Arm II (Temozolomide, Veliparib) | 43 | 218 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants3
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 |
| P50CA108961 | Mayo SPORE in Brain Cancer | O'NEILL, BRIAN PATRICK | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2004 to 2015 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm II (Temozolomide, Veliparib) vs Arm I (Temozolomide, Placebo): deaths from any cause | Trial comparisons |
| Arm II (Temozolomide, Veliparib) vs Arm I (Temozolomide, Placebo): Objective Tumor Response | Trial comparisons |
| Arm II (Temozolomide, Veliparib) vs Arm I (Temozolomide, Placebo): 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/NCT02152982
GET https://conductscience.org/api/trials/v1/NCT02152982/events?page=2