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Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148902
First Posted: September 8, 2005
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).

Condition Intervention Phase
Neoplasms, Breast Drug: lapatinib Drug: docetaxel Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:
  • Number of subjects with adverse events (AEs) or serious AEs (SAEs) [ Time Frame: Up to 7 weeks in each cycle ]
    An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention will be categorized as SAE.

  • Number of subjects with abnormal change from Baseline in laboratory parameters [ Time Frame: Baseline and up to 7 weeks in each cycle ]
    Blood sample will be collected to evaluate laboratory parameters.

  • Number of subjects with Optimally Tolerated regimen [ Time Frame: Up to 7 weeks in each cycle ]
    Optimally Tolerated regimen is a dose regimen where 1 out of 6 subjects experiences a dose-limiting toxicity (DLT).


Secondary Outcome Measures:
  • Area under the plasma drug concentration curve (AUC) from 0 to infinity (AUC[0-inf]) of docetaxel alone (Pharmacokinetic [PK] cohort 1) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • AUC within the dosing interval (AUC[0-tau]) of GW572016 alone (PK cohort 2) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 1) [ Time Frame: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 2) [ Time Frame: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Maximum observed plasma drug concentration (Cmax) of docetaxel alone (PK cohort 1) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Cmax of GW572016 alone (PK cohort 2) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Cmax of GW572016 when given in combination with docetaxel (PK cohort 1) [ Time Frame: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Cmax of GW572016 when given in combination with docetaxel (PK cohort 2) [ Time Frame: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Time to maximum observed plasma drug concentration (Tmax) of docetaxel alone (PK cohort 1) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Tmax of GW572016 alone (PK cohort 2) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Tmax of GW572016 when given in combination with docetaxel (PK cohort 1) [ Time Frame: Sequence 1, Day 22 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Tmax of GW572016 when given in combination with docetaxel (PK cohort 2) [ Time Frame: Sequence 1, Day 23 and Sequence 2, Day 1: Prior to the GW572016 oral dose and docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the start of the docetaxel infusion ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Concentration at the last measurable time point (Ctau) for GW572016 along (PK cohort 2) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Time to first measurable plasma drug concentration (Tlag) for GW572016 along (PK cohort 2) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 21: Prior to GW572016 dose and at 20 and 40 minutes; 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after the dose. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • AUC from time zero to time of last measurable concentration (AUClast) for docetaxel alone (PK cohort 1) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Clearance (CL) for docetaxel alone (PK cohort 1) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Volume of distribution at steady state (Vss) for docetaxel alone (PK cohort 1) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Elimination half-life (Thalf) for docetaxel alone (PK cohort 1) [ Time Frame: Sequence 1, Day 1 and Sequence 2, Day 22: Prior to the docetaxel infusion, at 20 and 40 minutes after the start of the infusion, at 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 hours after start of the infusion. ]
    Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.

  • Number of subjects with complete response [ Time Frame: Week 3 of every third cycle ]
    Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.

  • Number of subjects with partial response [ Time Frame: Week 3 of every third cycle ]
    Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.

  • Number of subjects with stable disease [ Time Frame: Week 3 of every third cycle ]
    Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.

  • Number of subjects with progressive disease [ Time Frame: Week 3 of every third cycle ]
    Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.


Enrollment: 52
Actual Study Start Date: April 28, 2003
Study Completion Date: January 21, 2006
Primary Completion Date: January 21, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All treated subjects
All subjects received Lapatinib in Combination with Docetaxel (Taxotere)
Drug: lapatinib
lapatinib
Drug: docetaxel
docetaxel

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced solid tumors.
  • Able to swallow oral medication.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148902


Locations
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00148902     History of Changes
Other Study ID Numbers: EGF10021
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by GlaxoSmithKline:
tumor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Lapatinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors