A Phase 2/3 interventional study of Laboratory Biomarker Analysis and Placebo Administration in Glioblastoma and Gliosarcoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 391 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by National Cancer Institute (NCI) · Phase 2/3, Interventional, and Treatment
This randomized phase II/III trial studies how well temozolomide and veliparib work compared to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme.
PRIMARY OBJECTIVE:
I. Test whether the experimental combination of ABT-888 (veliparib) combined with TMZ (temozolomide), compared to the control of placebo combined with TMZ, significantly extends overall survival in newly diagnosed glioblastoma multiforme (GBM) patients with tumor MGMT promoter hypermethylation.
SECONDARY OBJECTIVES:
I. Test whether the experimental treatment significantly extends progression-free survival.
II. Test whether the experimental treatment improves objective tumor response. III. Test whether the experimental treatment is associated with significantly greater rates of grade 3 or higher adverse events.
CORRELATIVE SCIENCE OBJECTIVES:
I. Evaluate the utility of dynamic susceptibility contrast (DSC) and diffusion weighted imaging (DWI) magnetic resonance imaging (MRI) techniques in defining time to progression in the setting of a large multi-institutional clinical trial.
II. Test the concordance between site-determined MGMT methylation status and central laboratory determination of MGMT status in cases with local testing.
III. Evaluate whether genetic or epigenetic alterations in deoxyribonucleic acid (DNA) repair or replication genes are associated with overall survival, progression-free survival, and objective tumor response.
IV. Test whether polymorphisms in MGMT, PARP1, or other DNA repair proteins, are associated with overall survival, progression-free survival, objective tumor response, or rates of grade 3 or higher adverse events.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5 and placebo PO twice daily (BID) on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.
ARM II: Patients receive temozolomide as in Arm I and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years, every 6 months for 2 years.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 447 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Prior treatment:
Not pregnant and not nursing; females of must have negative urine or serum pregnancy test within 7 days of registration but before start of treatment; a female of childbearing potential is a sexually mature female who:
Comorbid conditions: patients are unable to participate due to the following:
Patients must have adequate organ and marrow function measured within 28 days prior to administration of ABT-888 as defined below:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive temozolomide PO QD on days 1-5 and placebo PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.
Other: Laboratory Biomarker Analysis · Other: Placebo Administration · Other: Quality-of-Life Assessment · Drug: Temozolomide · Drug: Veliparib
Patients receive temozolomide as in Arm I and veliparib PO BID on days 1-7. Treatment repeats every 28 days for 6 cycles in the absence of disease progression (confirmed progression) or unacceptable toxicity.
Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Drug: Temozolomide · Drug: Veliparib
Correlative studies
Given PO
Ancillary studies
Also known as: Quality of Life Assessment
Given PO
Also known as: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temizole, Temodal, Temodar, Temomedac, TMZ
Given PO
Also known as: ABT 888, ABT-888, ABT888, PARP-1 inhibitor ABT-888
Overall Survival (OS)
The distribution of OS for each arm will be estimated using the Kaplan-Meier method and compared with a stratified logrank test.
Time frame: 83 months
Interaction With Optune Device
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.
Time frame: 10 years
Progression-free Survival (PFS)
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
Time frame: 120 months
Objective Tumor Response
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
Time frame: 5 years
Overall Adverse Event Rates for Grade 3 or Higher Adverse Events
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.
Time frame: 5 years
Change in Quality of Life (QOL)
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.
Time frame: Baseline to up to 5 years
MGMT Status
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.
Time frame: Baseline
| Milestone | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) |
|---|---|---|
| Started | 224 | 223 |
| Started treatment | 213 | 218 |
| Completed | 144 | 134 |
| Not completed | 80 | 89 |
| Withdrew: Withdrawal by subject | 17 | 16 |
| Withdrew: Did not start treatment | 11 | 5 |
| Withdrew: Disease progression | 41 | 52 |
| Withdrew: Adverse event | 7 | 12 |
| Withdrew: Complicating disease | 1 | 1 |
| Withdrew: Death | 0 | 3 |
| Withdrew: Physician decision | 3 | 0 |
The distribution of OS for each arm will be estimated using the Kaplan-Meier method and compared with a stratified logrank test.
| months | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) |
|---|---|---|
| Overall Survival (OS) | 24.8 (22.6 to 27.7) | 28.1 (24.3 to 33.3) |
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.
| participants | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) |
|---|---|---|
| Reporting actual Optune use | 42 | 42 |
| No actual Optune use | 182 | 181 |
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
| months | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) |
|---|---|---|
| Progression-free Survival (PFS) | 12.1 (10.6 to 14.9) | 13.2 (10.5 to 14.9) |
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
| Participants | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) |
|---|---|---|
| Objective Tumor Response | 34 | 37 |
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.
| participants with at least 1 grade 3+ AE | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) |
|---|---|---|
| Overall Adverse Event Rates for Grade 3 or Higher Adverse Events | 93 | 133 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over All-Cause Mortality monitored/assessed for up to 83 months; Adverse Events monitored/assessed for up to 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Temozolomide, Placebo) | 175/213 (82.2%) | 47/213 (22.1%) | 207/213 (97.2%) |
| Arm II (Temozolomide, Veliparib) | 183/218 (83.9%) | 43/218 (19.7%) | 217/218 (99.5%) |
| Event | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) |
|---|---|---|
| FatigueGeneral disorders | 8/213 | 7/218 |
| SeizureNervous system disorders | 5/213 | 7/218 |
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 6/213 | 3/218 |
| Thromboembolic eventVascular disorders | 4/213 | 6/218 |
| HyperglycemiaMetabolism and nutrition disorders | 2/213 | 5/218 |
| ConfusionPsychiatric disorders | 4/213 | 3/218 |
| SyncopeNervous system disorders | 2/213 | 3/218 |
| DiarrheaGastrointestinal disorders | 2/213 | 1/218 |
| VomitingGastrointestinal disorders | 2/213 | 1/218 |
| DehydrationMetabolism and nutrition disorders | 2/213 | 1/218 |
| Event | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) |
|---|---|---|
| Platelet count decreasedInvestigations | 116/213 | 191/218 |
| FatigueGeneral disorders | 182/213 | 181/218 |
| NauseaGastrointestinal disorders | 129/213 | 126/218 |
| Neutrophil count decreasedInvestigations | 45/213 | 115/218 |
| HeadacheNervous system disorders | 109/213 | 99/218 |
| ConstipationGastrointestinal disorders | 99/213 | 94/218 |
| AnorexiaMetabolism and nutrition disorders | 88/213 | 83/218 |
| White blood cell decreasedInvestigations | 27/213 | 62/218 |
| Lymphocyte count decreasedInvestigations | 60/213 | 60/218 |
| DiarrheaGastrointestinal disorders | 40/213 | 45/218 |
| Age, Continuous(years) | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) | Total |
|---|---|---|---|
| Mean | 58.3 ± 12.40 | 58.8 ± 11.55 | 58.5 ± 11.97 |
| Sex: Female, Male(Participants) | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) | Total |
|---|---|---|---|
| Female | 94 | 96 | 190 |
| Male | 130 | 127 | 257 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 7 | 16 |
| Not Hispanic or Latino | 208 | 212 | 420 |
| Unknown or Not Reported | 7 | 4 | 11 |
| Race (NIH/OMB)(Participants) | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 4 | 4 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 6 | 17 |
| White | 197 | 199 | 396 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 11 | 14 | 25 |
| Extent of Resection(Participants) | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) | Total |
|---|---|---|---|
| Gross total resection | 140 | 140 | 280 |
| Subtotal resection or biopsy | 84 | 83 | 167 |
| ECOG Performance Status(Participants) | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) | Total |
|---|---|---|---|
| 0-1 | 205 | 205 | 410 |
| 2 | 19 | 18 | 37 |
| Side of Lesion(Participants) | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) | Total |
|---|---|---|---|
| Bilateral | 3 | 8 | 11 |
| Left | 107 | 106 | 213 |
| Midline | 1 | 2 | 3 |
| Right | 113 | 107 | 220 |
| Tumor Location(Participants) | Arm I (Temozolomide, Placebo) | Arm II (Temozolomide, Veliparib) | Total |
|---|---|---|---|
| Multiple locations | 82 | 74 | 156 |
| Frontal | 67 | 65 | 132 |
| Occipital | 3 | 9 | 12 |
| Other | 1 | 3 | 4 |
| Parietal | 26 | 24 | 50 |
| Temporal | 42 | 45 | 87 |
| Thalamus | 3 | 3 | 6 |
1 further baseline measures are reported on the registry.
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PDFs hosted by the registry, ClinicalTrials.gov.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Temozolomide · Veliparib
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