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

Phase 2

Completed

• Conditions: Advanced Renal Cell Carcinoma
• Interventions: Drug: ABT-869

• Registration Number: NCT00486538
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-12
• Study First Posted: 2007-06-14
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Disposition First Submitted: 2012-06-29
• Disposition First Submitted QC: 2012-06-29
• Disposition First Posted: 2012-07-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	ABT-869	One oral dose daily

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	From randomization until patient death or alive at 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Site Reference ID/Investigator# 5379; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 7193; 🇺🇸 Sacramento, California, United States

Site Reference ID/Investigator# 5243; 🇺🇸 Washington, District of Columbia, United States

Site Reference ID/Investigator# 5384; 🇺🇸 Chicago, Illinois, United States

Site Reference ID/Investigator# 11663; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 11662; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 5380; 🇺🇸 Lebanon, New Hampshire, United States

Site Reference ID/Investigator# 6278; 🇺🇸 Philadelphia, Pennsylvania, United States

Site Reference ID/Investigator# 6269; 🇺🇸 Pittsburgh, Pennsylvania, United States

Site Reference ID/Investigator# 7300; 🇺🇸 Charleston, South Carolina, United States

Site Reference ID/Investigator# 5249; 🇺🇸 Philadelphia, Pennsylvania, United States

Site Reference ID/Investigator# 6796; 🇺🇸 Houston, Texas, United States

Site Reference ID/Investigator# 6566; 🇨🇦 Vancouver, Canada