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Tracking Information | |
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First Received Date † | August 17, 2005 |
Last Updated Date | December 4, 2007 |
Start Date † | August 2005 |
Current Primary Outcome Measures † |
Reduction in tumor blood flow and permeability of vessels |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00131651 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |
Brief Title † | ATN-161 in Advanced Renal Cell Cancer |
Official Title † | A Dose-Ranging, Phase II, Open Label Study of ATN 161 in Advanced Renal Cell Cancer |
Brief Summary | The purpose of this study is to determine an active dose of ATN-161 for future studies while establishing preliminary evidence of effectiveness in patients with renal cell cancer. |
Detailed Description | Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a requirement for the growth of nearly all tumors. Clear cell renal cell carcinoma (CCRCC) is a malignancy characterized by abundant vascularization and a high degree of resistance to chemotherapy which makes antiangiogenic therapy an intriguing concept for treatment. This concept has been established by the initial successes observed in recent studies of antiangiogenic therapies for CCRCC. ATN-161 is an attractive candidate for investigation as a therapeutic agent in CCRCC because it binds to several fully activated integrins, which are essential downstream components in the angiogenic signaling cascade. Functional imaging using dceMRI has been demonstrated as an effective way to show effects on the vasculature across different tumors, including CCRCC. Preclinical experiments have shown that ATN-161 affects tumor perfusion in tumor bearing mice. Therefore, use of imaging in this study is expected to be an effective method for evaluating the antiangiogenic response to ATN-161. Patients will be administered ATN-161 three times weekly by short (10 minute) IV infusion at 1 of 3 dose levels (20, 100, and 600 mg). Patients will be treated until progression of disease, unacceptable drug toxicity, or withdrawal of consent occurs. Functional imaging (dceMRI) will be performed within 1 week prior to first treatment, again during the second week of treatment, and finally during the fourth week of treatment. |
Study Phase | Phase II |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study |
Condition † | Carcinoma, Renal Cell |
Intervention † | Drug: ATN-161 |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Terminated |
Enrollment † | 36 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00131651 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | Attenuon |
Collaborators †† | |
Investigators † | |
Information Provided By | Attenuon |
Verification Date | December 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |