Lung Adenocarcinoma, Lung Adenocarcinoma, Mixed Subtype, Lung Large Cell Carcinoma, Lung Squamous Cell Carcinoma, Minimally Invasive Lung Adenocarcinoma, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage III Lung Non-Small Cell Cancer AJCC v7
Conditions
Brief summary
This phase I/II partially randomized trial studies the side effects and best dose of veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see how well it works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. It is not yet known whether radiation therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) and the recommended phase II dose of ABT-888 (veliparib) when given concurrently with standard carboplatin/paclitaxel and radiotherapy in patients with unresectable stage III non-small cell lung cancer (NSCLC). (Phase I) II. To assess whether carboplatin/paclitaxel plus ABT-888 compared with carboplatin/paclitaxel plus placebo improves progression-free survival (PFS) in patients with unresectable stage III NSCLC. (Phase II) III. To compare overall survival (OS) in patients treated with carboplatin/paclitaxel and radiotherapy plus ABT-888 to those treated with carboplatin, paclitaxel and radiotherapy plus placebo. (Phase II) IV. To assess the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate in the subset of patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. (Phase II) V. To assess the safety and toxicity profile of the regimen. (Phase II) SECONDARY OBJECTIVES: I. To collect tumor tissue from pretreatment biopsies (archival samples) for biomarker studies, including poly (ADP-ribose) polymerase 1 (PARP) activity by measuring the levels of poly-ADP-ribose, gamma-H2A histone family, member X (gamma-H2AX), and messenger ribonucleic acid (mRNA) expression levels of deoxyribonucleic acid (DNA) repair enzymes such as excision repair cross-complementing rodent repair deficiency, complementation group 1 (ERCC1)/x-ray repair complementing defective repair in Chinese hamster cells 1 (XRCC1). II. To collect blood samples for evaluation of gamma-H2AX (circulating tumor cells) and other relevant future studies. OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a randomized phase II study. PHASE I: INDUCTION THERAPY: Patients undergo 3-dimensional conformal radiation therapy (3D-CRT) once daily (QD), 5 days a week, for 6 weeks. Patients also receive veliparib orally (PO) twice daily (BID) on days 1-43 and carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 36, and 43 in the absence of disease progression or unacceptable toxicity. Patients without disease progression after completion of chemoradiotherapy undergo consolidation therapy. CONSOLIDATION THERAPY: Beginning within 4-6 weeks of chemotherapy and radiation therapy, patients receive veliparib PO BID on days 1-7 (course 1) and 22-28 (course 2) and carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1 and on day 22 of course 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy. ARM II: Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I. After completion of study treatment, patients are followed up every 4 months for first 2 years and then every 6 months until 5 years.
Interventions
RADIATION3-Dimensional Conformal Radiation Therapy
Undergo 3D-conformal RT
DRUGCarboplatin
Given IV
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGPaclitaxel
Given IV
OTHERPlacebo Administration
Given PO
DRUGVeliparib
Given PO
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically-proven new diagnosis of unresectable stage IIIA/IIIB\*, non-small cell lung cancer (adenocarcinoma, bronchioloalveolar cell carcinoma, large cell carcinoma, squamous cell carcinoma, or mixed) * Per the American Joint Committee on Cancer (AJCC) 7th edition, pleural and pericardial are now considered stage M1a disease; when pleural fluid is visible on the computed tomography (CT) scan or on a chest x-ray, a thoracentesis is required to confirm that the pleural fluid is cytologically negative; patients with exudative pleural effusions are excluded, regardless of cytology; patients with effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible; a small effusion that has positive fludeoxyglucose F 18 (FDG) uptake on positron emission tomography (PET) has to be proven to be malignant per standard of care diagnostic procedures for the patient to be excluded * Patients must have measurable or non-measurable disease documented by CT, magnetic resonance imaging (MRI) or PET/CT; the CT from a combined PET/CT may be used to document only non-measurable disease unless the scan is of diagnostic quality; measurable disease must be assessed by CT within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form * Patients with brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration * Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for lung cancer * Patients must not have received prior chest radiation therapy for NSCLC * Patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining the diagnosis, stage or potential resectability of newly diagnosed lung tumor; at least 28 days must have elapsed since thoracic surgery (excluding mediastinoscopy or other minor surgeries) and patients should have recovered from all associated toxicities at the time of registration; patients must not be planning to undergo a minor surgical procedure while on this study * Patients must have Zubrod performance status 0-1 * Patients must have tumor tissue available for submission to assess gene expression of ERCC1 and XRCC1; patients must also be offered participation in banking for future use of specimens * Absolute neutrophil count \>= 1,500/mcl * Platelets \>= 100,000/mcl * Hemoglobin \>= 9.0 g/dl * Total bilirubin within institutional upper limit of normal (IULN) * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x IULN * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Patients must have a serum creatinine =\< the IULN AND measured or calculated creatinine clearance \>= 60 cc/min using the Cockroft-Gault formula * Patients must have pulmonary function tests (PFTs) including forced expiratory volume in 1 second (FEV1) within 84 days prior to registration; for FEV1, the best value obtained pre- or post-bronchodilator must be \>= 1.2 liters/second and/or \>= 50% predicted * Patients may not be planning to receive any other investigational agents * Patients must not have more than 10% weight loss in the past 6 months * Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888, carboplatin, paclitaxel or other agents used in study * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years * Patient must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients must not currently have a \> grade 1 symptomatic neuropathy-sensory (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0) * Patients must not have a history of seizures * Patients must not have any known immune deficiencies; patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, known human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study * Patients must be able to swallow whole capsules * Prestudy history and physical must be obtained within 28 days prior to registration * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have completed chemoradiotherapy per protocol and at least four weeks but no more than six weeks must have elapsed from the last day of induction therapy (the last day of radiation) * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have undergone restaging tests according to the study calendar and determined to have no evidence of disease progression * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have a serum creatinine =\< (IULN) AND measured of calculated creatinine clearance \>= 60 cc/min using the Cockroft-Gault formula * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Absolute neutrophil count \>= 1,500 mcl * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Platelets \>= 100,000/mcl * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Hemoglobin \>= 9.0 g/dl * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Total bilirubin =\< IULN * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: SGOT (AST) or SGPT (ALT) =\< 2.5 x IULN * REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have Zubrod performance status 0-1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I) | 9 weeks | DLTs will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. DLTs must be attributable (probably, possibly, definitely related) to the study regimen and only occur during RT or 2 weeks after completing RT. DLTs are defined as: 1. Radiation esophagitis or dermatitis radiation Grade 3 that lasts \> 7 consecutive days or Grade 4 2. Grade 4 neutropenia for \> 7 days or neutropenic fever ( ANC \<500 and temperature \>= 38.5 oC) 3. Grade 4 thrombocytopenia 4. Grade 4 nausea/vomiting despite appropriate antiemetic therapy 5. Delays in radiotherapy or chemotherapy or ABT-888 due to toxicity of \> 3 weeks 6. All other non-hematologic toxicities \>= Grade 3, except * anorexia * fatigue * infection without neutropenia * Grade 3 AST/ALT elevations \<= 7 days, infusion reactions * Grade 3 or 4 lymphopenia * Grade 3 or 4 electrolyte abnormalities that are corrected to \<=Grade 2 in \< 48 hours * Grade 3 dehydration lasting \< 7 days |
| Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II) | The time from randomization to progression or death due to any cause, assessed up to 5 years | Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed by Response Evaluation Criteria in Solid Tumors, RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (Phase II) | Up to 5 years | From date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact. |
| Objective Response Rate (Phase II) | Up to 5 years | ORR is defined as the percentage of participants with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 |
| Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Duration of treatment and follow up until death or 5 years post registration | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAthanassios (Ethan) Argiris
SWOG Cancer Research Network
Participant flow
Pre-assignment details
In phase I, 21 participants were enrolled (8 on 40mg cohort, 7 on 80mg cohort and 6 on 120mg cohort separately). All 21 participants met the eligibility criterial. 14 of 21 participants later went on to consolidation therapy. In phase II, 32 participants were enrolled. 1 was ineligible and thus excluded from analysis. 18 of 31 eligible participants were randomized to veliparib arm and 13 participants to the placebo arm. 23 of 31 eligible participants later on went on to consolidation therapy
Participants by arm
| Arm | Count |
|---|---|
| Phase I 40mg Veliparib Cohort Participants undergo 3D-CRT and receive 40 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO | 8 |
| Phase I 80mg Veliparib Cohort Participants undergo 3D-CRT and receive 80 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO | 7 |
| Phase I 120mg Veliparib Cohort Participants undergo 3D-CRT and receive 120 mg veliparib, carboplatin, and paclitaxel during RT 3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Veliparib: Given PO | 6 |
| Arm I (RT, Veliparib, Carboplatin, Paclitaxel) Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.
3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Veliparib: Given PO | 18 |
| Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel) Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.
3-Dimensional Conformal Radiation Therapy: Undergo 3D-conformal RT
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Placebo Administration: Given PO | 13 |
| Total | 52 |
Baseline characteristics
| Characteristic | Phase I 120mg Veliparib Cohort | Arm I (RT, Veliparib, Carboplatin, Paclitaxel) | Phase I 40mg Veliparib Cohort | Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel) | Total | Phase I 80mg Veliparib Cohort |
|---|---|---|---|---|---|---|
| Age, Continuous | 69.7 years | 64.7 years | 69.2 years | 65.0 years | 67.0 years | 66.5 years |
| Baseline LDH Elevated | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 8 Participants | 2 Participants |
| Baseline LDH Normal | 6 Participants | 16 Participants | 4 Participants | 9 Participants | 40 Participants | 5 Participants |
| Baseline LDH Not reported | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 18 Participants | 8 Participants | 13 Participants | 51 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Histology Adenocarcinoma | 3 Participants | 8 Participants | 5 Participants | 8 Participants | 28 Participants | 4 Participants |
| Histology Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Histology Squamous cell | 2 Participants | 10 Participants | 3 Participants | 5 Participants | 23 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 13 Participants | 7 Participants | 12 Participants | 43 Participants | 6 Participants |
| Sex: Female, Male Female | 1 Participants | 11 Participants | 3 Participants | 6 Participants | 24 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 5 Participants | 7 Participants | 28 Participants | 4 Participants |
| Smoking Status Current smoker | 3 Participants | 8 Participants | 1 Participants | 6 Participants | 18 Participants | 0 Participants |
| Smoking Status Former status | 1 Participants | 9 Participants | 6 Participants | 7 Participants | 29 Participants | 6 Participants |
| Smoking Status Never smoker | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants | 1 Participants |
| Stage IIIA | 6 Participants | 7 Participants | 5 Participants | 5 Participants | 28 Participants | 5 Participants |
| Stage IIIB | 0 Participants | 11 Participants | 3 Participants | 8 Participants | 24 Participants | 2 Participants |
| Weight loss past 6 months <5% | 6 Participants | 14 Participants | 3 Participants | 8 Participants | 37 Participants | 6 Participants |
| Weight loss past 6 months 5%-10% | 0 Participants | 4 Participants | 5 Participants | 5 Participants | 15 Participants | 1 Participants |
| Zubrod Performance Status 0 | 4 Participants | 7 Participants | 3 Participants | 3 Participants | 21 Participants | 4 Participants |
| Zubrod Performance Status 1 | 2 Participants | 11 Participants | 5 Participants | 10 Participants | 31 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 8 | 5 / 7 | 2 / 6 | 8 / 18 | 8 / 13 | 3 / 4 | 3 / 5 | 2 / 5 | 7 / 13 | 6 / 10 |
| other Total, other adverse events | 8 / 8 | 7 / 7 | 6 / 6 | 17 / 17 | 13 / 13 | 4 / 4 | 4 / 5 | 5 / 5 | 12 / 12 | 9 / 10 |
| serious Total, serious adverse events | 3 / 8 | 3 / 7 | 2 / 6 | 2 / 17 | 3 / 13 | 1 / 4 | 0 / 5 | 1 / 5 | 3 / 12 | 1 / 10 |
Outcome results
Primary
Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I)
DLTs will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. DLTs must be attributable (probably, possibly, definitely related) to the study regimen and only occur during RT or 2 weeks after completing RT. DLTs are defined as: 1. Radiation esophagitis or dermatitis radiation Grade 3 that lasts \> 7 consecutive days or Grade 4 2. Grade 4 neutropenia for \> 7 days or neutropenic fever ( ANC \<500 and temperature \>= 38.5 oC) 3. Grade 4 thrombocytopenia 4. Grade 4 nausea/vomiting despite appropriate antiemetic therapy 5. Delays in radiotherapy or chemotherapy or ABT-888 due to toxicity of \> 3 weeks 6. All other non-hematologic toxicities \>= Grade 3, except * anorexia * fatigue * infection without neutropenia * Grade 3 AST/ALT elevations \<= 7 days, infusion reactions * Grade 3 or 4 lymphopenia * Grade 3 or 4 electrolyte abnormalities that are corrected to \<=Grade 2 in \< 48 hours * Grade 3 dehydration lasting \< 7 days
Time frame: 9 weeks
Population: Eligible participants evaluable for dose limiting toxicity assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I 40mg Veliparib | Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I) | 1 dose limiting toxicity |
| Phase I 80mg Veliparib | Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I) | 1 dose limiting toxicity |
| Phase I 120mg Veliparib | Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I) | 0 dose limiting toxicity |
Primary
Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed by Response Evaluation Criteria in Solid Tumors, RECIST 1.1
Time frame: The time from randomization to progression or death due to any cause, assessed up to 5 years
Population: All eligible participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I 40mg Veliparib | Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II) | 9.3 months |
| Phase I 80mg Veliparib | Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II) | 9.9 months |
Secondary
Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II)
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Duration of treatment and follow up until death or 5 years post registration
Population: Up to 4 weeks after completion of consolidation therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hyponatremia | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypomagnesemia | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Fatigue | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Upper gastrointestinal hemorrhage | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypokalemia | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypoglycemia | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hyperglycemia | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Dehydration | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypocalcemia | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Weight loss | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Pneumonitis | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Platelet count decreased | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Diarrhea | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Anemia | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Neutrophil count decreased | 3 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Nausea | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Dysphagia | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Anorexia | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Mucositis oral | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Lymphocyte count decreased | 3 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Esophageal pain | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | White blood cell decreased | 2 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Lung infection | 0 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypotension | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Esophagitis | 1 Participants |
| Phase I 40mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Vomiting | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Diarrhea | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Anemia | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Anorexia | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Dehydration | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Dysphagia | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Esophageal pain | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Esophagitis | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Fatigue | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hyperglycemia | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypocalcemia | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypoglycemia | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypokalemia | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypomagnesemia | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hyponatremia | 3 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypotension | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Lung infection | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Lymphocyte count decreased | 4 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Mucositis oral | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Nausea | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Neutrophil count decreased | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Platelet count decreased | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Pneumonitis | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Upper gastrointestinal hemorrhage | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Vomiting | 1 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Weight loss | 0 Participants |
| Phase I 80mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | White blood cell decreased | 2 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Esophagitis | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hyponatremia | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Anorexia | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypotension | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Esophageal pain | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Lung infection | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Vomiting | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Lymphocyte count decreased | 2 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Dysphagia | 2 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Mucositis oral | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Nausea | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Diarrhea | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | White blood cell decreased | 2 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Neutrophil count decreased | 3 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Weight loss | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Platelet count decreased | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Dehydration | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Pneumonitis | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hyperglycemia | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypocalcemia | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypoglycemia | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Fatigue | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Anemia | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypokalemia | 0 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Upper gastrointestinal hemorrhage | 1 Participants |
| Phase I 120mg Veliparib | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypomagnesemia | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypocalcemia | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Upper gastrointestinal hemorrhage | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Neutrophil count decreased | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hyponatremia | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Esophageal pain | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Dehydration | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Fatigue | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypotension | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Anorexia | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | White blood cell decreased | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Platelet count decreased | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Lung infection | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Dysphagia | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypomagnesemia | 1 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Weight loss | 1 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Lymphocyte count decreased | 2 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypoglycemia | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Vomiting | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hyperglycemia | 1 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Mucositis oral | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Diarrhea | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Anemia | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Hypokalemia | 1 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Nausea | 0 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Pneumonitis | 1 Participants |
| Arm II Consolidation (Placebo, Carboplatin, Paclitaxel) | Incidence of Serious (>= Grade 3) Adverse Events as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase II) | Esophagitis | 0 Participants |
Secondary
Objective Response Rate (Phase II)
ORR is defined as the percentage of participants with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Time frame: Up to 5 years
Population: All eligible participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I 40mg Veliparib | Objective Response Rate (Phase II) | 56 percentage of participants |
| Phase I 80mg Veliparib | Objective Response Rate (Phase II) | 69 percentage of participants |
Secondary
Overall Survival (Phase II)
From date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
Time frame: Up to 5 years
Population: All eligible participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase I 40mg Veliparib | Overall Survival (Phase II) | 27.6 months |
| Phase I 80mg Veliparib | Overall Survival (Phase II) | 15.2 months |