stop_circleTerminated/Withdrawn

Carcinoma, Renal Cell

Mechanistic evaluation on sorafenib induced hypophosphatemia.

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
12
Trial Dates
May 2008 - November 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Mayo Clinic - RochesterRochester, 55905, United States
Terminated
Mayo Clinic - ScottsdaleScottsdale, 85259, United States
Terminated
Stony Brook University Medical CenterStony Brook, 11794-944, United States
Terminated
Hackensack University Medical CenterHackensack, 07601, United States
Completed
Barbara Ann Karmanos Cancer InstituteDetroit, 48201, United States
Completed
Loyola University Medical CenterMaywood, 60153, United States
Completed
Mayo Clinic - JacksonvilleJacksonville, 32224, United States

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
    date_rangeTime Frame:
    Occur when the last query is resolved
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • To assess the effect of sorafenib treatment on left ventricular ejection fraction (LVEF) and B-type Natriuretic Peptide (BNP) in plasma
    date_rangeTime Frame:
    Occur when the last query is resolved
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Mechanistic evaluations on sorafenib induced hypophosphatemia in patients with advanced renal cell carcinoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1