Last updated: 11/04/2018 06:20:48

Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

GSK study ID
EGF10021
See study documents
Clinicaltrials.gov ID
NCT00148902
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination with Docetaxel (Taxotere)
Trial description: This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with adverse events (AEs) or serious AEs (SAEs)

Timeframe: Up to 7 weeks in each cycle

Number of subjects with abnormal change from Baseline in laboratory parameters

Timeframe: Baseline and up to 7 weeks in each cycle

Number of subjects with Optimally Tolerated regimen

Timeframe: Up to 7 weeks in each cycle

Secondary outcomes:

Area under the plasma drug concentration curve (AUC) from 0 to infinity (AUC[0-inf]) of docetaxel alone (Pharmacokinetic [PK] cohort 1)

Timeframe: 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.

AUC within the dosing interval (AUC[0-tau]) of GW572016 alone (PK cohort 2)

Timeframe: 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.

AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 1)

Timeframe: 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.

AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 2)

Timeframe: 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

Maximum observed plasma drug concentration (Cmax) of docetaxel alone (PK cohort 1)

Timeframe: 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.

Cmax of GW572016 alone (PK cohort 2)

Timeframe: 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.

Cmax of GW572016 when given in combination with docetaxel (PK cohort 1)

Timeframe: 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.

Cmax of GW572016 when given in combination with docetaxel (PK cohort 2)

Timeframe: 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

Time to maximum observed plasma drug concentration (Tmax) of docetaxel alone (PK cohort 1)

Timeframe: 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.

Tmax of GW572016 alone (PK cohort 2)

Timeframe: 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.

Tmax of GW572016 when given in combination with docetaxel (PK cohort 1)

Timeframe: 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.

Tmax of GW572016 when given in combination with docetaxel (PK cohort 2)

Timeframe: 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

Concentration at the last measurable time point (Ctau) for GW572016 along (PK cohort 2)

Timeframe: 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.

Time to first measurable plasma drug concentration (Tlag) for GW572016 along (PK cohort 2)

Timeframe: 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.

AUC from time zero to time of last measurable concentration (AUClast) for docetaxel alone (PK cohort 1)

Timeframe: 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.

Clearance (CL) for docetaxel alone (PK cohort 1)

Timeframe: 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.

Volume of distribution at steady state (Vss) for docetaxel alone (PK cohort 1)

Timeframe: 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.

Elimination half-life (Thalf) for docetaxel alone (PK cohort 1)

Timeframe: 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.

Number of subjects with complete response

Timeframe: Week 3 of every third cycle

Number of subjects with partial response

Timeframe: Week 3 of every third cycle

Number of subjects with stable disease

Timeframe: Week 3 of every third cycle

Number of subjects with progressive disease

Timeframe: Week 3 of every third cycle

Interventions:
  • Drug: lapatinib
  • Drug: docetaxel
    • Enrollment:
    52
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    April 2003 to January 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Advanced solid tumors.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Advanced solid tumors.
    • Able to swallow oral medication.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48201
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-21-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study EGF10021 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website