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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the treatment of subjects with advanced renal cell carcinoma who have previously received treatment with sunitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | One oral dose daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-869 | Drug | One oral dose daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | From randomization until patient death or alive at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free rate | Week 16 | |
| Best response rate | From randomization until patient death or alive at 2 years | |
| Time to tumor progression |
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Inclusion Criteria
Exclusion Criteria
Subject has received anti-cancer therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration.
Subject has untreated brain or meningeal metastases.
Subject has received a tyrosine kinase inhibitor (TKI) other than sunitinib or sorafenib.
Prior use of Avastin is allowed.
The subject is receiving therapeutic anticoagulation therapy.
The subject has a history of/or currently exhibits clinically significant cancer related events of bleeding (e.g., hematuria, hemoptysis).
The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 100 mmHg; or systolic blood pressure (BP) > 150 mmHg.
The subject has a history of myocardial infarction within 6 months of Study Day 1.
The subject has a documented left ventricular (LV) Ejection Fraction < 50%.
The subject has known autoimmune disease with renal involvement (eg, Lupus).
Female subjects who are pregnant or breast feeding.
Subject is receiving anti-retroviral therapy for HIV.
Subject has a clinically significant uncontrolled condition(s) including but not limited to:
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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# 7193 | Sacramento | California | 95817 | United States | ||
| Site Reference ID/Investigator# 5243 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22078932 | Derived | Tannir NM, Wong YN, Kollmannsberger CK, Ernstoff MS, Perry DJ, Appleman LJ, Posadas EM, Cho D, Choueiri TK, Coates A, Gupta N, Pradhan R, Qian J, Chen J, Scappaticci FA, Ricker JL, Carlson DM, Michaelson MD. Phase 2 trial of linifanib (ABT-869) in patients with advanced renal cell cancer after sunitinib failure. Eur J Cancer. 2011 Dec;47(18):2706-14. doi: 10.1016/j.ejca.2011.09.002. Epub 2011 Nov 10. |
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| From randomization until patient death or alive at 2 years |
| Progression free survival | Radiographic evaluation every month, clinical evaluation every 4 weeks |
| Overall Survival | Two-year follow-up post study |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Site Reference ID/Investigator# 5384 | Chicago | Illinois | 60637 | United States |
| Site Reference ID/Investigator# 11662 | Boston | Massachusetts | 02114 | United States |
| Site Reference ID/Investigator# 11663 | Boston | Massachusetts | 02114 | United States |
| Site Reference ID/Investigator# 5379 | Boston | Massachusetts | 02114 | United States |
| Site Reference ID/Investigator# 5380 | Lebanon | New Hampshire | 03756-0001 | United States |
| Site Reference ID/Investigator# 5249 | Philadelphia | Pennsylvania | 19111 | United States |
| Site Reference ID/Investigator# 6278 | Philadelphia | Pennsylvania | 19111 | United States |
| Site Reference ID/Investigator# 6269 | Pittsburgh | Pennsylvania | 15232 | United States |
| Site Reference ID/Investigator# 7300 | Charleston | South Carolina | 29425 | United States |
| Site Reference ID/Investigator# 6796 | Houston | Texas | 77030-4009 | United States |
| Site Reference ID/Investigator# 6566 | Vancouver | V5Z 4E6 | Canada |
| ID | Term |
|---|---|
| C513486 | linifanib |
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