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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003618-18 | EudraCT Number |
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The primary objective of this study is to evaluate the efficacy and safety of veliparib and whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veliparib 200 mg BID + WBRT | Experimental | Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
|
| Veliparib 50 mg BID + WBRT | Experimental | Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
|
| Placebo BID + WBRT | Placebo Comparator | Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veliparib | Drug | Veliparib capsules for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the number of days from the date of randomization to the date of death. All events of death were included, regardless of whether the event occurred while the participant was still taking study treatment or after treatment was discontinued. If a participant had not died, the data were censored at the date the participant was last known to be alive. | From randomization up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Tumor Response Rate | Best tumor response rate was calculated as the percentage of participants with a complete response or partial response, as determined by brain scan imaging (magnetic resonance image or computed tomography) by a central imaging vendor. Response was assessed according to the modified bidimensional criteria: Complete response required all of the following: complete disappearance of all target and non-target lesions sustained for at least 4 weeks; no new lesions, including no new leptomeningeal disease; no systemic corticosteroid dose. Partial response required all of the following: ≥ 50% decrease compared with baseline in the size of all target lesions sustained for at least 4 weeks; no new lesions, including no new leptomeningeal disease and no unequivocal progression of non-target lesions, which, even in presence of stable disease or progressive disease in target lesions, was significant enough to qualify as progression; stable or reduced daily total systemic corticosteroid dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Giranda, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27655223 | Result | Chabot P, Hsia TC, Ryu JS, Gorbunova V, Belda-Iniesta C, Ball D, Kio E, Mehta M, Papp K, Qin Q, Qian J, Holen KD, Giranda V, Suh JH. Veliparib in combination with whole-brain radiation therapy for patients with brain metastases from non-small cell lung cancer: results of a randomized, global, placebo-controlled study. J Neurooncol. 2017 Jan;131(1):105-115. doi: 10.1007/s11060-016-2275-x. Epub 2016 Sep 21. |
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Subjects were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified by graded prognostic assessment (GPA) score (≤ 2.5 versus > 2.5) and neurological symptoms (symptomatic versus asymptomatic).
Participants were enrolled across 87 sites in Argentina, Australia, Belgium, Canada, Chile, Czech Republic, Egypt, Finland, France, Hungary, Korea, Norway, Russia, Spain, Taiwan, Ukraine, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo BID + WBRT | Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
| FG001 | Veliparib 50 mg BID + WBRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo to veliparib capsules for oral administration |
|
| Whole brain radiation therapy | Radiation | 30.0 grays (Gy) of WBRT given in 10 daily fractions of 3.0 Gy each, excluding weekends and holidays |
|
| From randomization up to 24 months |
| Time to Intracranial Progression (Radiographic) | Time to intracranial progression (radiographic) was defined as the number of days from the date of randomization to the date of the first intracranial progression, as determined by brain scan imaging (magnetic resonance image [MRI]/ computed tomography [CT] scan) by a central imaging vendor. All confirmed events of intracranial progression were included, regardless of whether the event occurred while the participant was still taking study treatment or had previously discontinued study treatment. If the participant did not have a confirmed event of intracranial progression, their data were censored at the date of the last available intracranial progression assessment. Time to intracranial progression (radiographic) was estimated for each treatment group using Kaplan-Meier methodology. | From randomization up to 24 months |
| Time to Clinical Brain Metastasis Progression | Time to clinical brain metastases progression was defined as the number of days from randomization to the date of the first experience of clinical brain metastases progression, as assessed by a team of neuro-oncology experts (Event Review Board). All events of clinical brain metastasis progression were included, regardless of whether the event occurred while the participant was still receiving study treatment or had previously discontinued study treatment. If a participant did not have an event of clinical brain metastases progression, their data were censored at the date of the last available clinical disease progression assessment. Time to clinical brain metastasis progression was estimated for each treatment group using Kaplan-Meier methodology. | From randomization up to 24 months |
Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
| FG002 | Veliparib 200 mg BID + WBRT | Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo BID + WBRT | Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
| BG001 | Veliparib 50 mg BID + WBRT | Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
| BG002 | Veliparib 200 mg BID + WBRT | Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Graded Prognostic Assessment (GPA) | A participant's GPA score was the sum total of each of the following prognostic factors, scored as 0, 0.5, or 1:
| Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Overall survival was defined as the number of days from the date of randomization to the date of death. All events of death were included, regardless of whether the event occurred while the participant was still taking study treatment or after treatment was discontinued. If a participant had not died, the data were censored at the date the participant was last known to be alive. | All randomized participants | Posted | Median | 95% Confidence Interval | days | From randomization up to 36 months |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Tumor Response Rate | Best tumor response rate was calculated as the percentage of participants with a complete response or partial response, as determined by brain scan imaging (magnetic resonance image or computed tomography) by a central imaging vendor. Response was assessed according to the modified bidimensional criteria: Complete response required all of the following: complete disappearance of all target and non-target lesions sustained for at least 4 weeks; no new lesions, including no new leptomeningeal disease; no systemic corticosteroid dose. Partial response required all of the following: ≥ 50% decrease compared with baseline in the size of all target lesions sustained for at least 4 weeks; no new lesions, including no new leptomeningeal disease and no unequivocal progression of non-target lesions, which, even in presence of stable disease or progressive disease in target lesions, was significant enough to qualify as progression; stable or reduced daily total systemic corticosteroid dose. | All randomized participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Intracranial Progression (Radiographic) | Time to intracranial progression (radiographic) was defined as the number of days from the date of randomization to the date of the first intracranial progression, as determined by brain scan imaging (magnetic resonance image [MRI]/ computed tomography [CT] scan) by a central imaging vendor. All confirmed events of intracranial progression were included, regardless of whether the event occurred while the participant was still taking study treatment or had previously discontinued study treatment. If the participant did not have a confirmed event of intracranial progression, their data were censored at the date of the last available intracranial progression assessment. Time to intracranial progression (radiographic) was estimated for each treatment group using Kaplan-Meier methodology. | All randomized participants | Posted | Median | 95% Confidence Interval | days | From randomization up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Clinical Brain Metastasis Progression | Time to clinical brain metastases progression was defined as the number of days from randomization to the date of the first experience of clinical brain metastases progression, as assessed by a team of neuro-oncology experts (Event Review Board). All events of clinical brain metastasis progression were included, regardless of whether the event occurred while the participant was still receiving study treatment or had previously discontinued study treatment. If a participant did not have an event of clinical brain metastases progression, their data were censored at the date of the last available clinical disease progression assessment. Time to clinical brain metastasis progression was estimated for each treatment group using Kaplan-Meier methodology. | All randomized participants | Posted | Median | 95% Confidence Interval | days | From randomization up to 24 months |
|
From first dose of study drug until 30 days following last dose of study drug; median duration of treatment was 15 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo BID + WBRT | Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. | 39 | 101 | 78 | 101 | ||
| EG001 | Veliparib 50 mg BID + WBRT | Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. | 31 | 103 | 76 | 103 | ||
| EG002 | Veliparib 200 mg BID + WBRT | Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. | 36 | 102 | 77 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PROCTALGIA | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| BACTERIAL INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| NOSOCOMIAL INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| ORAL FUNGAL INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| PNEUMONIA STREPTOCOCCAL | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| INTRACRANIAL TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Systematic Assessment |
| |
| ALTERED STATE OF CONSCIOUSNESS | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| DEMENTIA | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| HAEMORRHAGIC STROKE | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| HEMIPLEGIA | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| NERVE COMPRESSION | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| STATUS EPILEPTICUS | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| VASOGENIC CEREBRAL OEDEMA | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PULMONARY ARTERY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| THROMBOPHLEBITIS | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (17.0) | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| |
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (17.0) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| C521013 | veliparib |
Not provided
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| ≥ 65 years |
|
| Male |
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| Black |
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| Asian |
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| Native Hawaiian or Pacific Islander |
|
| Multirace |
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| > 2.5 |
|
| The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025. | Log Rank | Log-rank test stratified by GPA score (≤ 2.5 or > 2.5) at screening. Nominal P-values were reported. | 0.909 | Superiority |
| Cox proportional hazard model | Cox proportional hazard model stratified by GPA score (≤ 2.5 or > 2.5) at screening. Nominal P-values were reported. | 0.927 | Hazard Ratio (HR) | 0.985 | 2-Sided | 95 | 0.716 | 1.355 | Superiority |
| Cox proportional hazard model | Cox proportional hazard model stratified by GPA score (≤ 2.5 or > 2.5) at screening. Nominal P-values were reported. | 0.906 | Hazard Ratio (HR) | 0.981 | 2-Sided | 95 | 0.710 | 1.354 | Superiority |
Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.
| OG002 | Veliparib 200 mg BID + WBRT | Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
|
|
|
| OG002 | Veliparib 200 mg BID + WBRT | Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
|
|
|
| OG002 | Veliparib 200 mg BID + WBRT | Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays. |
|
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