check_circleStudy Completed

Neoplasms

Sorafenib/Docetaxel Dose Escalation Trial

Trial purpose

The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
17
Trial Dates
November 2007 - March 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
H. Lee Moffitt Cancer Center & Research InstituteTampa, 33612, United States
Completed
Fox Chase Cancer CenterPhiladelphia, 19111-2497, United States

Primary Outcome

  • To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib
    date_rangeTime Frame:
    6 weeks
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    Safety Issue:
    yes

Secondary Outcome

  • To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A Phase I dose escalation study with sorafenib administered continuously in combination with docetaxel administered once every three weeks in patients with advanced solid tumors.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1