Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

November 7, 2008 updated by: Pfizer

A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors

This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35233-2115
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Advanced solid tumor malignancy ECOG 0 or 1

Exclusion Criteria:

Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
SU011248 in combination with docetaxel
Drug: sunitinib
25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)
Drug: docetaxel
60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
Time Frame: November 2007
November 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel.
Time Frame: November 2007
November 2007
Objective disease response
Time Frame: November 2007
November 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

November 11, 2008

Last Update Submitted That Met QC Criteria

November 7, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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