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Mechanistic Evaluation on Sorafenib Induced Hypophosphatemia.

NCT00622479 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-12-18

No results posted yet for this study

Summary

The purpose of this study is to:

1. To elucidate the mechanism involved in the sorafenib-induced hypophosphatemia and possible early effect of hypophosphatemia on bone mineral density
2. A secondary objective to assess the effect sorafenib treatment on evaluate left ventricular function (LVEF) and Beta-type natriuretic peptide in plasma.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Sorafenib will be administered at 400mg BID for a 28 day cycle.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-10-31
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622479 on ClinicalTrials.gov