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

This is an interventional treatment trial for Advanced Renal Cell Carcinoma Read More

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.