Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

Neoplasms, Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148902
• Other study ID #: EGF10021
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2005
• Last updated: December 4, 2017
• Start date: April 28, 2003
• Est. completion date: January 21, 2006

Study information

• Verified date: December 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 21, 2006
• Est. primary completion date: January 21, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced solid tumors.

• Able to swallow oral medication.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Breast

Intervention

Drug:
• lapatinib
lapatinib
• docetaxel
docetaxel

Locations

Country	Name	City	State
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Area under the plasma drug concentration curve (AUC) from 0 to infinity (AUC[0-inf]) of docetaxel alone (Pharmacokinetic [PK] cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	AUC within the dosing interval (AUC[0-tau]) of GW572016 alone (PK cohort 2)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	AUC (0-tau) of GW572016 when given in combination with docetaxel (PK cohort 2)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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
Secondary	Maximum observed plasma drug concentration (Cmax) of docetaxel alone (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Cmax of GW572016 alone (PK cohort 2)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Cmax of GW572016 when given in combination with docetaxel (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Cmax of GW572016 when given in combination with docetaxel (PK cohort 2)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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
Secondary	Time to maximum observed plasma drug concentration (Tmax) of docetaxel alone (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Tmax of GW572016 alone (PK cohort 2)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Tmax of GW572016 when given in combination with docetaxel (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Tmax of GW572016 when given in combination with docetaxel (PK cohort 2)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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
Secondary	Concentration at the last measurable time point (Ctau) for GW572016 along (PK cohort 2)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Time to first measurable plasma drug concentration (Tlag) for GW572016 along (PK cohort 2)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	AUC from time zero to time of last measurable concentration (AUClast) for docetaxel alone (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Clearance (CL) for docetaxel alone (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Volume of distribution at steady state (Vss) for docetaxel alone (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Elimination half-life (Thalf) for docetaxel alone (PK cohort 1)	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.	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.
Secondary	Number of subjects with complete response	Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.	Week 3 of every third cycle
Secondary	Number of subjects with partial response	Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.	Week 3 of every third cycle
Secondary	Number of subjects with stable disease	Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.	Week 3 of every third cycle
Secondary	Number of subjects with progressive disease	Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.	Week 3 of every third cycle

External Links

•   Results for study EGF10021 can be found on the GSK Clinical Study Register.