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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007107-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 12.5 mg ABT-869 + Carboplatin/Paclitaxel |
|
| B | Experimental | 7.5 mg ABT-869 + Carboplatin/Paclitaxel |
|
| C | Placebo Comparator | Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-869 | Drug | 12.5 mg ABT-869 |
| |
| Placebo for ABT-869 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Disease Progression |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response | Disease Progression | |
| Survival Rate | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin L. Ricker, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 15850 | Chandler | Arizona | 85224 | United States | ||
| Site Reference ID/Investigator# 15846 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25559798 | Derived | Ramalingam SS, Shtivelband M, Soo RA, Barrios CH, Makhson A, Segalla JG, Pittman KB, Kolman P, Pereira JR, Srkalovic G, Belani CP, Axelrod R, Owonikoko TK, Qin Q, Qian J, McKeegan EM, Devanarayan V, McKee MD, Ricker JL, Carlson DM, Gorbunova VA. Randomized phase II study of carboplatin and paclitaxel with either linifanib or placebo for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2015 Feb 10;33(5):433-41. doi: 10.1200/JCO.2014.55.7173. Epub 2015 Jan 5. |
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| Drug |
Placebo Comparator (12.5 mg or 7.5 mg) |
|
|
| ABT-869 | Drug | 7.5 mg ABT-869 |
|
| Carboplatin | Drug | Carboplatin (AUC 6 mg/mL/min) |
|
| Paclitaxel | Drug | Paclitaxel (200 mg/m2) |
|
| Peoria |
| Arizona |
| 85381 |
| United States |
| Site Reference ID/Investigator# 15841 | Miami | Florida | 33136 | United States |
| Site Reference ID/Investigator# 7179 | Atlanta | Georgia | 30322 | United States |
| Site Reference ID/Investigator# 15851 | Lansing | Michigan | 48912 | United States |
| Site Reference ID/Investigator# 15844 | Lebanon | New Hampshire | 03756 | United States |
| Site Reference ID/Investigator# 22443 | Hackensack | New Jersey | 07601 | United States |
| Site Reference ID/Investigator# 15848 | Greensboro | North Carolina | 27403 | United States |
| Site Reference ID/Investigator# 22444 | Canton | Ohio | 44718 | United States |
| Site Reference ID/Investigator# 15847 | Cleveland | Ohio | 44195 | United States |
| Site Reference ID/Investigator# 26842 | Hershey | Pennsylvania | 17033-0850 | United States |
| Site Reference ID/Investigator# 13101 | Philadelphia | Pennsylvania | 19106 | United States |
| Site Reference ID/Investigator# 24122 | Philadelphia | Pennsylvania | 19107 | United States |
| Site Reference ID/Investigator# 19042 | Bedford Park | 5042 | Australia |
| Site Reference ID/Investigator# 23682 | Cairns | 4870 | Australia |
| Site Reference ID/Investigator# 21862 | Lismore | 2480 | Australia |
| Site Reference ID/Investigator# 19043 | Woodville South | 5011 | Australia |
| Site Reference ID/Investigator# 17703 | Jaú | 17210-120 | Brazil |
| Site Reference ID/Investigator# 23522 | Porto Alegre | 90050-170 | Brazil |
| Site Reference ID/Investigator# 15601 | Porto Alegre | 90610-000 | Brazil |
| Site Reference ID/Investigator# 17704 | Rio de Janeiro | 20231-050 | Brazil |
| Site Reference ID/Investigator# 22684 | Santo André | 09060-650 | Brazil |
| Site Reference ID/Investigator# 17702 | São Paulo | 01224-010 | Brazil |
| Site Reference ID/Investigator# 23582 | São Paulo | 04024-002 | Brazil |
| Site Reference ID/Investigator# 18964 | Kyjov | 69733 | Czechia |
| Site Reference ID/Investigator# 22504 | Náchod | 54769 | Czechia |
| Site Reference ID/Investigator# 18963 | Olomouc | 77520 | Czechia |
| Site Reference ID/Investigator# 18962 | Prague | 12808 | Czechia |
| Site Reference ID/Investigator# 19022 | Pribram V | 26995 | Czechia |
| Site Reference ID/Investigator# 38003 | Kazan' | 420029 | Russia |
| Site Reference ID/Investigator# 38260 | Kirov | 610021 | Russia |
| Site Reference ID/Investigator# 18064 | Moscow | 115478 | Russia |
| Site Reference ID/Investigator# 18065 | Moscow | 115478 | Russia |
| Site Reference ID/Investigator# 23312 | Moscow | 115478 | Russia |
| Site Reference ID/Investigator# 18066 | Moscow | 143423 | Russia |
| Site Reference ID/Investigator# 23562 | Saint Petersburg | 198255 | Russia |
| Site Reference ID/Investigator# 18961 | Singapore | 119228 | Singapore |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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 |
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| ID | Term |
|---|---|
| C513486 | linifanib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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