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Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00148902
First received: September 6, 2005
Last updated: October 6, 2008
Last verified: October 2008
History of Changes
  Purpose

This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).


Condition Intervention Phase
Solid Tumor Cancer
 Drug: lapatinib and docetaxel
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Docetaxel (TAXOTERE)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety and Tolerability

Secondary Outcome Measures:
  • Pharmacokinetics

Estimated Enrollment: 50
Study Start Date: April 2003
Intervention Details:
    Drug: lapatinib and docetaxel
    Other Name: lapatinib and docetaxel
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced solid tumors.
  • Able to swallow oral medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148902

Locations
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00148902     History of Changes
Other Study ID Numbers: EGF10021
Study First Received: September 6, 2005
Last Updated: October 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
tumor

Additional relevant MeSH terms:
Docetaxel
Lapatinib
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013