Clinical Trial: Mechanistic Evaluation on Sorafenib Induced Hypophosphatemia.
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Mechanistic Evaluations on Sorafenib Induced Hypophosphatemia in Patients With Advanced Renal Cell Carcinoma
Brief Summary:
The purpose of this study is to:
- To elucidate the mechanism involved in the sorafenib-induced hypophosphatemia and possible early effect of hypophosphatemia on bone mineral density
- A secondary objective to assess the effect sorafenib treatment on evaluate left ventricular function (LVEF) and Beta-type natriuretic peptide in plasma.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: To evaluate a potential mechanism of hypophosphatemia related to sorafenib treatment based on measurement of phosphate regulating factors, peptides, and related laboratory variables [ Time Frame: Occur when the last query is resolved ]
Original Primary Outcome: The primary objective is to evaluate a potential mechanism of hypophosphatemia related to sorafenib treatment based on measurement of phosphate regulating factors, peptides, and related laboratory variables. [ Time Frame: Occur when the last query is resolved 01-Sep-09 ]
Current Secondary Outcome: To assess the effect of sorafenib treatment on left ventricular ejection fraction (LVEF) and B-type Natriuretic Peptide (BNP) in plasma [ Time Frame: Occur when the last query is resolved ]
Original Secondary Outcome: A secondary objective of the study is to assess the effect of sorafenib treatment on left ventricular ejection fraction (LVEF) and B-type Natriuretic Peptide (BNP) in plasma. [ Time Frame: Occur when the last query is resolved 01-Sep-09 ]
Information By: Bayer
Dates:
Date Received: February 13, 2008
Date Started: May 2008
Date Completion:
Last Updated: December 17, 2014
Last Verified: December 2014