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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002838-38 | EudraCT Number |
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To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Docetaxel + ABT-751 |
|
| B | Placebo Comparator | Docetaxel + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-751 | Drug | 200mg ABT-751 daily for 14 days every 21 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Subjects may remain on study until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Subject may remain on study until disease progression | |
| Response Rate | Subject may remain on study until disease progression | |
| Time-to-Progression (TTP) |
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Inclusion Criteria:
ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Eliopoulos, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 3572 | Birmingham | Alabama | 35294-3300 | United States | ||
| Site Ref # / Investigator 4771 |
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| Drug |
Placebo daily for 14 days every 21 days |
|
| Docetaxel | Drug | Standard Docetaxel every 21 days |
|
|
| Subject may remain on study until disease progression |
| Burbank |
| California |
| 91505 |
| United States |
| Site Ref # / Investigator 3574 | Orange | California | 92868-3298 | United States |
| Site Ref # / Investigator 3567 | Rancho Mirage | California | 92270 | United States |
| Site Ref # / Investigator 3512 | Gurnee | Illinois | 60031 | United States |
| Site Ref # / Investigator 3565 | Hackensack | New Jersey | 07601 | United States |
| Site Ref # / Investigator 3569 | Buffalo | New York | 14215 | United States |
| Site Ref # / Investigator 3511 | Cleveland | Ohio | 44195 | United States |
| Site Ref # / Investigator 5237 | Ravenna | Ohio | 44266 | United States |
| Site Ref # / Investigator 3551 | Crossville | Tennessee | 38555 | United States |
| Site Ref # / Investigator 3549 | Knoxville | Tennessee | 37920 | United States |
| Site Ref # / Investigator 3571 | Nashville | Tennessee | 37232-6307 | United States |
| Site Ref # / Investigator 3510 | Weston | Wisconsin | 54476 | United States |
| Site Ref # / Investigator 3563 | Sydney | Nova Scotia | B1P 1P3 | Canada |
| Site Ref # / Investigator 3559 | Barrie | Ontario | L4M 6M2 | Canada |
| Site Ref # / Investigator 3561 | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Site Ref # / Investigator 3560 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Site Ref # / Investigator 3562 | Montreal | Quebec | H2W 1S6 | Canada |
| Site Ref # / Investigator 2222 | Montreal | Quebec | H3T 1E2 | Canada |
| Site Ref # / Investigator 3558 | Regina | Saskatchewan | S4T 7T1 | Canada |
| Site Ref # / Investigator 5097 | Cork | Ireland |
| Site Ref # / Investigator 4971 | Dublin | Ireland |
| Site Ref # / Investigator 4986 | Dublin | Ireland |
| Site Ref # / Investigator 4999 | Dublin | Ireland |
| Site Ref # / Investigator 5158 | Dublin | Ireland |
| Site Ref # / Investigator 5259 | Belfast | BT9 7AB | United Kingdom |
| Site Ref # / Investigator 5270 | East Barming | ME16 9QQ | United Kingdom |
| Site Ref # / Investigator 5271 | Edinburgh | EH42XU | United Kingdom |
| Site Ref # / Investigator 5017 | Glasgow | G12 0YN | United Kingdom |
| Site Ref # / Investigator 5274 | Hull | HU8 9HE | United Kingdom |
| Site Ref # / Investigator 5273 | Surrey | GU2 7XX | United Kingdom |
| Site Ref # / Investigator 5268 | Surrey | SM2 5NG | United Kingdom |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C490492 | ABT751 |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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