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

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ClinicalTrials.gov Identifier: NCT00486538
Recruitment Status : Completed
First Posted : June 14, 2007
Last Update Posted : January 4, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Renal Cell Carcinoma Drug: ABT-869 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm
One oral dose daily
 Drug: ABT-869
One oral dose daily.


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: From randomization until patient death or alive at 2 years ]

Secondary Outcome Measures :
  1. Progression-free rate [ Time Frame: Week 16 ]
  2. Best response rate [ Time Frame: From randomization until patient death or alive at 2 years ]
  3. Time to tumor progression [ Time Frame: From randomization until patient death or alive at 2 years ]
  4. Progression free survival [ Time Frame: Radiographic evaluation every month, clinical evaluation every 4 weeks ]
  5. Overall Survival [ Time Frame: Two-year follow-up post study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486538


Locations
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United States, California
Site Reference ID/Investigator# 7193
Sacramento, California, United States, 95817
United States, District of Columbia
Site Reference ID/Investigator# 5243
Washington, District of Columbia, United States, 20010
United States, Illinois
Site Reference ID/Investigator# 5384
Chicago, Illinois, United States, 60637
United States, Massachusetts
Site Reference ID/Investigator# 11662
Boston, Massachusetts, United States, 02114
Site Reference ID/Investigator# 11663
Boston, Massachusetts, United States, 02114
Site Reference ID/Investigator# 5379
Boston, Massachusetts, United States, 02114
United States, New Hampshire
Site Reference ID/Investigator# 5380
Lebanon, New Hampshire, United States, 03756-0001
United States, Pennsylvania
Site Reference ID/Investigator# 5249
Philadelphia, Pennsylvania, United States, 19111
Site Reference ID/Investigator# 6278
Philadelphia, Pennsylvania, United States, 19111
Site Reference ID/Investigator# 6269
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Site Reference ID/Investigator# 7300
Charleston, South Carolina, United States, 29425
United States, Texas
Site Reference ID/Investigator# 6796
Houston, Texas, United States, 77030-4009
Canada
Site Reference ID/Investigator# 6566
Vancouver, Canada, V5Z 4E6
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Investigators
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Study Director: Justin L. Ricker, MD AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00486538    
Other Study ID Numbers: M06-882
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases