NCT00148902

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2003

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2006

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

2.7 years

First QC Date

September 6, 2005

Last Update Submit

December 4, 2017

Conditions

Neoplasms, Breast

Keywords

tumor

Outcome Measures

Primary Outcomes (3)

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

    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.

    Up to 7 weeks in each cycle

  • Number of subjects with abnormal change from Baseline in laboratory parameters

    Blood sample will be collected to evaluate laboratory parameters.

    Baseline and up to 7 weeks in each cycle

  • Number of subjects with Optimally Tolerated regimen

    Optimally Tolerated regimen is a dose regimen where 1 out of 6 subjects experiences a dose-limiting toxicity (DLT).

    Up to 7 weeks in each cycle

Secondary Outcomes (22)

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

    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)

    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)

    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)

    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)

    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.

  • +17 more secondary outcomes

Study Arms (1)

All treated subjects

EXPERIMENTAL

All subjects received Lapatinib in Combination with Docetaxel (Taxotere)

Drug: lapatinibDrug: docetaxel

Interventions

lapatinibDRUG

lapatinib

All treated subjects
docetaxelDRUG

docetaxel

All treated subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Detroit, Michigan, 48201, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

LapatinibDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

April 28, 2003

Primary Completion

January 21, 2006

Study Completion

January 21, 2006

Last Updated

December 6, 2017

Record last verified: 2017-12

Locations

US(2)