Clinical trial NCT00486538: Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Renal Cell Carcinoma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2007-06-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: From randomization until patient death or alive at 2 years
Secondary outcomes:
measure: Progression-free rate
timeFrame: Week 16
measure: Best response rate
timeFrame: From randomization until patient death or alive at 2 years
measure: Time to tumor progression
timeFrame: From randomization until patient death or alive at 2 years
measure: Progression free survival
timeFrame: Radiographic evaluation every month, clinical evaluation every 4 weeks
measure: Overall Survival
timeFrame: Two-year follow-up post study
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Site Reference ID/Investigator# 7193
state: California
city: Washington
country: United States
facility: Site Reference ID/Investigator# 5243
state: District of Columbia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 5384
state: Illinois
city: Boston
country: United States
facility: Site Reference ID/Investigator# 11662
state: Massachusetts
city: Boston
country: United States
facility: Site Reference ID/Investigator# 11663
state: Massachusetts
city: Boston
country: United States
facility: Site Reference ID/Investigator# 5379
state: Massachusetts
city: Lebanon
country: United States
facility: Site Reference ID/Investigator# 5380
state: New Hampshire
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 5249
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 6278
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site Reference ID/Investigator# 6269
state: Pennsylvania
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 7300
state: South Carolina
city: Houston
country: United States
facility: Site Reference ID/Investigator# 6796
state: Texas
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 6566
Study officials:
affiliation: AbbVie
name: Justin L. Ricker, MD
role: STUDY_DIRECTOR
References:
citation: 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.