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

NCT00486538 | Completed Phase 2

• 1 other identifier: M06-882
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  From randomization until patient death or alive at 2 years

Secondary Outcomes (5)

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

One oral dose daily

Drug: ABT-869

Interventions

ABT-869 DRUG

One oral dose daily.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Genentech, Inc.: collaborator

Study Sites (13)

Site Reference ID/Investigator# 7193

Sacramento, California, 95817, United States

Location

Site Reference ID/Investigator# 5243

Washington D.C., District of Columbia, 20010, United States

Location

Site Reference ID/Investigator# 5384

Chicago, Illinois, 60637, United States

Location

Site Reference ID/Investigator# 11662

Boston, Massachusetts, 02114, United States

Location

Site Reference ID/Investigator# 11663

Boston, Massachusetts, 02114, United States

Location

Site Reference ID/Investigator# 5379

Boston, Massachusetts, 02114, United States

Location

Site Reference ID/Investigator# 5380

Lebanon, New Hampshire, 03756-0001, United States

Location

Site Reference ID/Investigator# 5249

Philadelphia, Pennsylvania, 19111, United States

Location

Site Reference ID/Investigator# 6278

Philadelphia, Pennsylvania, 19111, United States

Location

Site Reference ID/Investigator# 6269

Pittsburgh, Pennsylvania, 15232, United States

Location

Site Reference ID/Investigator# 7300

Charleston, South Carolina, 29425, United States

Location

Site Reference ID/Investigator# 6796

Houston, Texas, 77030-4009, United States

Location

Site Reference ID/Investigator# 6566

Vancouver, V5Z 4E6, Canada

Location

Related Publications (1)

• 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.

  PMID: 22078932 DERIVED

MeSH Terms

Interventions

linifanib

Study Officials

• Justin L. Ricker, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 14, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

US (12); CA (1)