Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

Phase 1

Completed

• Conditions: Neoplasms, Breast
• Interventions: Drug: lapatinib; Drug: docetaxel

• Registration Number: NCT00148902
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04-28
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2006-01-21
• Study Completion: 2006-01-21
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
All treated subjects	docetaxel	All subjects received Lapatinib in Combination with Docetaxel (Taxotere)
All treated subjects	lapatinib	All subjects received Lapatinib in Combination with Docetaxel (Taxotere)

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events (AEs) or serious AEs (SAEs)	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	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	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 Outcome Measures

Name	Time	Method
Cmax 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.	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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.
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.	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)	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)	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)	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)	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 partial response	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	Week 3 of every third cycle	Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
Volume of distribution at steady state (Vss) for 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.	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Elimination half-life (Thalf) for 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.	Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
Number of subjects with complete response	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	Week 3 of every third cycle	Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Nashville, Tennessee, United States