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Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00486538•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+10 more criteria

Locations (13)

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

Key Dates

Start Date

June 1, 2007

Primary Completion Date

June 1, 2011

Completion Date

June 1, 2012

Last Updated

January 4, 2013

Enrollment

ACTUAL participants

Conditions

Advanced Renal Cell Carcinoma

Interventions

ABT-869

DRUG

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

NCT07227415

Carcinoma, Renal CellAdvanced Renal Cell Carcinoma+11 more

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RECRUITINGPHASE1

Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors

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Solid Tumor, AdultAdvanced Solid Tumor+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 4, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

Combination of 177Lu-TLX250 and Peposertib in Patients With Carbonic Anhydrase IX -Expressing Solid Tumors

CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer

Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study

Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study

STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma