check_circleStudy Completed

Neoplasms

Sorafenib/ Carboplatin/ Paclitaxel in patients with solid tumors

Trial purpose

The purpose of this study is to:

1.) Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin,
2.) Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and
3.) To determine the safety of sorafenib.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
16
Trial Dates
May 2007 - February 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Yale Cancer CenterNew Haven, 06511-5991, United States
Completed
South Texas Accelerated Research TherapeuticsSan Antonio, 78229-3307, United States

Primary Outcome

  • Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeks
    date_rangeTime Frame:
    2 years
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    Safety Issue:
    no

Secondary Outcome

  • To determine the safety profile and pharmacokinetics of oral sorafenib daily in combination with every 3-weekly carboplatin and paclitaxel.
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    no

Trial design

Phase I Study with sorafenib in combination with carboplatin and paclitaxel to evaluate the safety and pharmacokinetics of this combination in patients with solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1