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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014