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Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

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ClinicalTrials.gov Identifier: NCT00148902
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

September 6, 2005
September 8, 2005
December 6, 2017
April 28, 2003
January 21, 2006   (Final data collection date for primary outcome measure)
  • 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).
Safety and Tolerability
Complete list of historical versions of study NCT00148902 on ClinicalTrials.gov Archive Site
  • 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.
Pharmacokinetics
Not Provided
Not Provided
 
Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Docetaxel (Taxotere)
This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms, Breast
  • Drug: lapatinib
    lapatinib
  • Drug: docetaxel
    docetaxel
Experimental: All treated subjects
All subjects received Lapatinib in Combination with Docetaxel (Taxotere)
Interventions:
  • Drug: lapatinib
  • Drug: docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
January 21, 2006
January 21, 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced solid tumors.
  • Able to swallow oral medication.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00148902
EGF10021
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP