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

NCT ID: NCT00486538

Last Updated: 2013-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-06-30

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.

Conditions

Advanced Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

One oral dose daily

Group Type: EXPERIMENTAL

ABT-869

Intervention Type: DRUG

One oral dose daily.

Interventions

ABT-869

One oral dose daily.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin L. Ricker, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 7193

Sacramento, California, United States

Site Reference ID/Investigator# 5243

Washington D.C., District of Columbia, United States

Site Reference ID/Investigator# 5384

Chicago, Illinois, United States

Site Reference ID/Investigator# 11662

Boston, Massachusetts, United States

Site Reference ID/Investigator# 11663

Boston, Massachusetts, United States

Site Reference ID/Investigator# 5379

Boston, Massachusetts, United States

Site Reference ID/Investigator# 5380

Lebanon, New Hampshire, United States

Site Reference ID/Investigator# 5249

Philadelphia, Pennsylvania, 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# 6796

Houston, Texas, United States

Site Reference ID/Investigator# 6566

Vancouver, , Canada

Countries

United States; Canada

References

Tannir NM, Wong YN, Kollmannsberger CK, Ernstoff MS, Perry DJ, Appleman LJ, Posadas EM, Cho D, Choueiri TK, Coates A, Gupta N, Pradhan R, Qian J, Chen J, Scappaticci FA, Ricker JL, Carlson DM, Michaelson MD. Phase 2 trial of linifanib (ABT-869) in patients with advanced renal cell cancer after sunitinib failure. Eur J Cancer. 2011 Dec;47(18):2706-14. doi: 10.1016/j.ejca.2011.09.002. Epub 2011 Nov 10.

Reference Type: DERIVED

PMID: 22078932 (View on PubMed)

Other Identifiers

M06-882

Identifier Type: -

Identifier Source: org_study_id