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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001658-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veliparib and nivolumab with platinum doublet chemotherapy | Experimental | Veliparib and nivolumab in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) |
|
| Veliparib with platinum doublet chemotherapy | Experimental | Veliparib in combination with platinum doublet chemotherapy (carboplatin/paclitaxel or carboplatin/pemetrexed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | intravenous; administered on Day 1 via infusion in a 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS is defined as the number of days from the date of randomization to the date of earliest disease progression (radiographic progression per RECIST version 1.1 or clinical disease progression) or death. If the participant does not experience disease progression or death, then the data will be censored at the date of the last disease assessment. | 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). | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax for pemetrexed | Up to approximately 3 weeks | |
| AUC for nivolumab | Up to approximately 3.5 years | |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 155135 | Birmingham | Alabama | 35233 | United States | ||
| Icri /Id# 155593 |
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|
| nivolumab | Drug | intravenous; administered on Day 1 via infusion in a 21-day cycle |
|
|
| paclitaxel | Drug | intravenous; administered on Day 1 via infusion in a 21-day cycle |
|
|
| veliparib | Drug | oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle |
|
|
| carboplatin | Drug | intravenous; administered on Day 1 via infusion in a 21-day cycle |
|
|
OS is defined as the number of days from the date of randomization to the date of death. For subjects who did not die, their data will be censored at the date of last study visit or the last known date to be alive, whichever is later. |
| Up to approximately 3.5 years |
| Tmax for nivolumab | Up to approximately 3.5 years |
| AUC for pemetrexed | Up to approximately 3 weeks |
| Time to Cmax (peak time, Tmax) for veliparib | Up to approximately 9 weeks |
| Area under the plasma concentration-time curve (AUC) for veliparib | Up to approximately 9 weeks |
| Maximum observed serum concentration (Cmax) of nivolumab anti-drug antibody (ADA) | Up to approximately 3.5 years |
| Duration of Overall Response (DOR) | DOR is defined as the number of days from the date of first response (CR or PR) to the earliest documentation of progressive disease or death due to disease progression. | Up to approximately 3.5 years |
| Maximum observed plasma concentration (Cmax) for pemetrexed | Up to approximately 3 weeks |
| Maximum observed plasma concentration (Cmax) for veliparib | Up to approximately 9 weeks |
| Objective Response Rate (ORR) | ORR is defined as the proportion of the participants who have a complete response (CR) or partial response (PR). | Up to approximately 3.5 years |
| Whittier |
| California |
| 90603 |
| United States |
| Univ of Colorado Cancer Center /ID# 153820 | Aurora | Colorado | 80045 | United States |
| University of Chicago /ID# 153824 | Chicago | Illinois | 60637-1443 | United States |
| Goshen Center for Cancer Care /ID# 153822 | Goshen | Indiana | 46526 | United States |
| Duke University Medical Center /ID# 153821 | Durham | North Carolina | 27710-3000 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000077594 | Nivolumab |
| D017239 | Paclitaxel |
| C521013 | veliparib |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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