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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Renal Cell Carcinoma

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

From randomization until patient death or alive at 2 years

Safety Issue:

No

Principal Investigator

Justin L. Ricker, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M06-882

NCT ID:

NCT00486538

Start Date:

June 2007

Completion Date:

June 2012

Related Keywords:

  • Advanced Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Site Reference ID/Investigator# 7193Sacramento, California  95817
Site Reference ID/Investigator# 5243Washington, District of Columbia  20010
Site Reference ID/Investigator# 5384Chicago, Illinois  60637
Site Reference ID/Investigator# 11663Boston, Massachusetts  02114
Site Reference ID/Investigator# 11662Boston, Massachusetts  02114
Site Reference ID/Investigator# 5379Boston, Massachusetts  02114
Site Reference ID/Investigator# 5380Lebanon, New Hampshire  03756-0001
Site Reference ID/Investigator# 5249Philadelphia, Pennsylvania  19111
Site Reference ID/Investigator# 6278Philadelphia, Pennsylvania  19111
Site Reference ID/Investigator# 6269Pittsburgh, Pennsylvania  15232
Site Reference ID/Investigator# 7300Charleston, South Carolina  29425
Site Reference ID/Investigator# 6796Houston, Texas  77030-4009