Combination of Capecitabine and GTI-2040 in the Treatment of Renal Cell Carcinoma

Phase 1

Completed

• Conditions: Carcinoma, Renal Cell; Metastases, Neoplasm

• Registration Number: NCT00056173
• Lead Sponsor: Aptose Biosciences Inc.

Brief Summary

This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2003-03-06
• Study First Submitted QC: 2003-03-08
• Study First Posted: 2003-03-10
• Primary Completion: 2004-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-04
• Last Update Posted: 2008-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (10)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Innovative Medical Research of South Florida, Inc.; 🇺🇸 Miami Shores, Florida, United States

CA Hematology Oncology Medical Group; 🇺🇸 Torrance, California, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Bay Area Cancer Research Group; 🇺🇸 Concord, California, United States

USC-Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States