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

January 2, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Vancouver, Canada, V5Z 4E6
        • Site Reference ID/Investigator# 6566
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Site Reference ID/Investigator# 7193
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Site Reference ID/Investigator# 5243
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Site Reference ID/Investigator# 5384
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • 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
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0001
        • Site Reference ID/Investigator# 5380
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Site Reference ID/Investigator# 5249
      • Philadelphia, Pennsylvania, United States, 19111
        • Site Reference ID/Investigator# 6278
      • Pittsburgh, Pennsylvania, United States, 15232
        • Site Reference ID/Investigator# 6269
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Site Reference ID/Investigator# 7300
    • Texas
      • Houston, Texas, United States, 77030-4009
        • Site Reference ID/Investigator# 6796

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
One oral dose daily
Drug: ABT-869
One oral dose daily.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 12, 2007

First Submitted That Met QC Criteria

June 12, 2007

First Posted (Estimate)

June 14, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-882

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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