NCT00148902 — Effects Of GW572016 In Combination With Docetaxel (TAXOTERE) · CancerIndex

Clinical trial · Interventional

Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

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

NCT00148902CI-TRIAL-00030701completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoplasms, Breast	Breast Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
docetaxel	Drug	Docetaxel	ALIAS
lapatinib	Drug	Lapatinib	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
All treated subjects
description
All subjects received Lapatinib in Combination with Docetaxel (Taxotere)
interventionNames
1. Drug: lapatinib
2. Drug: docetaxel

Primary outcomes (3)

measure
Number of subjects with adverse events (AEs) or serious AEs (SAEs)
timeFrame
Up to 7 weeks in each cycle
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Apr 28, 2003
Primary completion: Jan 21, 2006
Completion: Jan 21, 2006
First posted: Sep 8, 2005
Last update posted: Dec 6, 2017
Enrollment: 52 (actual)
Lead sponsor: GlaxoSmithKline INDUSTRY
Keywords: tumor

Data updated 22 days agoSource updated Dec 6, 2017source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United States	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.

Secondary outcomes (22)

measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
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.
description
Blood samples will be collected at indicated time points to evaluate pharmacokinetic parameters.
measure
Number of subjects with complete response
timeFrame
Week 3 of every third cycle
description
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
measure
Number of subjects with partial response
timeFrame
Week 3 of every third cycle
description
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
measure
Number of subjects with stable disease
timeFrame
Week 3 of every third cycle
description
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.
measure
Number of subjects with progressive disease
timeFrame
Week 3 of every third cycle
description
Efficacy assessments will be obtained every three cycles depending on standard practices in specific tumor type.