Study of Veliparib in Combination With Nivolumab and Platinum Doublet Chemotherapy in Participants With Metastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)
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Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location University of Alabama at Birmingham - Main, Birmingham, Alabama, 35233 | Status Not Available | |
Location Icri, Whittier, California, 90603 | Status Not Available | |
Location Univ of Colorado Cancer Center, Aurora, Colorado, 80045 | Status Not Available | |
Location University of Chicago, Chicago, Illinois, 60637-1443 | Status Not Available | |
Location Goshen Center for Cancer Care, Goshen, Indiana, 46526 | Status Not Available | |
Location Duke University Medical Center, Durham, North Carolina, 27710-3000 | Status Not Available |
This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with nivolumab and platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) (Phase 1 portion) and to assess whether the addition of nivolumab to veliparib in combination with platinum doublet chemotherapy results will improve progression free survival (PFS) compared to veliparib with platinum doublet chemotherapy alone in participants with metastatic or advanced Non-small Cell Lung Cancer (NSCLC) (Phase 2 portion). A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.
Progression-free survival (PFS)
Time Frame: Up to approximately 3.5 years
Recommended Phase 2 dose (RPTD) of veliparib (ABT-888) in combination with nivolumab and platinum doublet chemotherapy in participants with metastatic or advanced Non-Small Cell Lung Cancer (NSCLC).
Time Frame: Up to 6 weeks
Tmax for pemetrexed
Time Frame: Up to approximately 3 weeks
AUC for nivolumab
Time Frame: Up to approximately 3.5 years
Overall Survival (OS)
Time Frame: Up to approximately 3.5 years
Tmax for nivolumab
Time Frame: Up to approximately 3.5 years
AUC for pemetrexed
Time Frame: Up to approximately 3 weeks
Time to Cmax (peak time, Tmax) for veliparib
Time Frame: Up to approximately 9 weeks
Area under the plasma concentration-time curve (AUC) for veliparib
Time Frame: Up to approximately 9 weeks
Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA)
Time Frame: Up to approximately 3.5 years
Duration of Overall Response (DOR)
Time Frame: Up to approximately 3.5 years
Maximum observed plasma concentration (Cmax) for pemetrexed
Time Frame: Up to approximately 3 weeks
Maximum observed plasma concentration (Cmax) for veliparib
Time Frame: Up to approximately 9 weeks
Objective Response Rate (ORR)
Time Frame: Up to approximately 3.5 years
Interventions:
- Drug: pemetrexed
- Drug: pemetrexed
- Drug: nivolumab
- Drug: paclitaxel
- Drug: paclitaxel
- Drug: veliparib
- Drug: veliparib
- Drug: carboplatin
- Drug: carboplatin
Enrollment:
25
Additional Information
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