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Completed

NCT Number: NCT00148902

Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

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

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Key information

Conditions

Neoplasms, Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Detroit, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced solid tumors.
  • Able to swallow oral medication.

Treatment and study plan

Lapatinib

Drug

lapatinib

docetaxel

Drug

docetaxel

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Docetaxel (Taxotere)

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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