Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Phase 2 Study to Evaluate the Efficacy and Tolerability of ABT-869 in Subjects With Advanced Renal Cell Carcinoma (RCC) Who Have Previously Received Treatment With Sunitinib

Conditions
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Advanced Renal Cell Carcinoma

Intervention / Treatment
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* Drug: ABT-869


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject has undergone previous nephrectomy. Subject has received at least 2 cycles (12 weeks) of treatment with sunitinib for RCC and stopped therapy due to progressive disease within 100 days prior to screening. Subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST. ECOG Performance Score of 0-1. No history of another active cancer within the past 5 years.Life expectancy of at least 4 months. Willing to take adequate measures to prevent pregnancy. 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: active uncontrolled infection, Class III or IV heart failure as defined by the New York Heart Association functional classification system, unstable angina pectoris or cardiac arrhythmia, history of adrenal insufficiency, psychiatric illness/social situation that would limit compliance with study requirements; Active, ulcerative colitis, Crohn's disease, celiadisease or any other conditions that interfere with absorption. Subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>One oral dose daily | Drug: ABT-869<br>* One oral dose daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | From randomization until patient death or alive at 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |