Clinical trial NCT00148902: Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)
Official title: A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Docetaxel (Taxotere)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Breast
Keywords: tumor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Number of subjects with adverse events (AEs) or serious AEs (SAEs)
timeFrame: Up to 7 weeks in each cycle
measure: Number of subjects with abnormal change from Baseline in laboratory parameters
timeFrame: Baseline and up to 7 weeks in each cycle
measure: Number of subjects with Optimally Tolerated regimen
timeFrame: Up to 7 weeks in each cycle
Secondary outcomes:
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
measure: Number of subjects with complete response
timeFrame: Week 3 of every third cycle
measure: Number of subjects with partial response
timeFrame: Week 3 of every third cycle
measure: Number of subjects with stable disease
timeFrame: Week 3 of every third cycle
measure: Number of subjects with progressive disease
timeFrame: Week 3 of every third cycle
Other outcomes:
Locations:
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: