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Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Abbott
Genentech
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00486538
  Purpose

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 Intervention Phase
Advanced Renal Cell Carcinoma
Drug: ABT-869
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Sunitinib Sunitinib malate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: study duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-Free Rate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Best Response Rate [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Time to Tumor Progression [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: study duration ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Two year follow-up post study ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: August 2007
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm: Experimental Drug: ABT-869
One oral dose daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 unidimensional 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, celiac disease 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486538

Locations
United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston,, Massachusetts, United States, 02215
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, British Columbia
British Columbia Cancer Research Centre
Vancouver, British Columbia, Canada, V5Z 1L3
Sponsors and Collaborators
Abbott
Genentech
  More Information

Responsible Party: Abbott ( Justin Ricker, MD PhD Global Medical Director Oncology )
Study ID Numbers: M06-882
Study First Received: June 12, 2007
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00486538  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms
Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009