Trial Outcomes & Findings for Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer (NCT NCT00291577)
NCT ID: NCT00291577
Last Updated: 2009-12-23
Results Overview
Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.
COMPLETED
PHASE1
22 participants
1, 2, 4, 6, 8, 12, 24 hours postdose
2009-12-23
Participant Flow
First 12 subjects evaluable for pharmacokinetic (PK) analysis had full PK profile on Cycle 1, Day 1 (C1D1) and C2D1.
Participant milestones
| Measure |
Sunitinib in Combination With Docetaxel
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Sunitinib in Combination With Docetaxel
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Other
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lack of Efficacy
|
14
|
Baseline Characteristics
Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib in Combination With Docetaxel
n=22 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Age, Customized
18 to 44 years
|
3 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
13 participants
n=5 Participants
|
|
Age, Customized
> = 65 years
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 2, 4, 6, 8, 12, 24 hours postdosePopulation: Evaluable set of subjects for PK analysis is subjects in ITT population who completed sampling for PK profiles for both SU011248 and docetaxel; ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).
Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=11 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU011248 C2D3
|
6.0 hours
Interval 2.0 to 8.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU012662 C1D2
|
6.0 hours
Interval 2.0 to 24.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU012662 C2D3
|
6.0 hours
Interval 4.0 to 24.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug C1D2
|
6.0 hours
Interval 2.0 to 24.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug C2D3
|
6.0 hours
Interval 2.0 to 8.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU011248 C1D2
|
6.0 hours
Interval 4.0 to 24.0
|
PRIMARY outcome
Timeframe: 1, 2, 4, 6, 8, 12, 24 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=11 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU011248 C1D2
|
29.17 ng/mL
Standard Deviation 7.906
|
|
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU012662 C1D2
|
5.07 ng/mL
Standard Deviation 2.385
|
|
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU012662 C2D3
|
5.91 ng/mL
Standard Deviation 2.251
|
|
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug C1D2
|
34.05 ng/mL
Standard Deviation 9.312
|
|
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug C2D3
|
34.69 ng/mL
Standard Deviation 8.941
|
|
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU011248 C2D3
|
29.49 ng/mL
Standard Deviation 7.910
|
PRIMARY outcome
Timeframe: 1, 2, 4, 6, 8, 12, 24 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng\*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=11 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU011248 C1D2
|
486.38 ng*hr/mL
Standard Deviation 132.439
|
|
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU011248 C2D3
|
479.80 ng*hr/mL
Standard Deviation 128.718
|
|
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU012662 C1D2
|
82.21 ng*hr/mL
Standard Deviation 33.204
|
|
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU012662 C2D3
|
96.88 ng*hr/mL
Standard Deviation 30.513
|
|
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug C1D2
|
568.78 ng*hr/mL
Standard Deviation 152.106
|
|
Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug C2D3
|
567.43 ng*hr/mL
Standard Deviation 145.952
|
PRIMARY outcome
Timeframe: 1, 2, 4, 6, 8, 12, 24 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0 hour postdosePopulation: Evaluable set of subjects for PK analysis; (n) = Number of observations above lower limit of quantification (NALQ). No participants analyzed for SU011248 C1D2 and SU012662 C1D2; standard deviation for Total drug C1D2 confirmed as 0.00 (median, minimum, and maximum = 0.20).
Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=18 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU011248 C1D15 (n=18)
|
52.06 ng/mL
Standard Deviation 23.05
|
|
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU011248 C2D1 (n=11)
|
5.00 ng/mL
Standard Deviation 5.14
|
|
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU012662 C1D15 (n=18)
|
21.75 ng/mL
Standard Deviation 8.85
|
|
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
SU012662 C2D1 (n=11)
|
4.88 ng/mL
Standard Deviation 3.52
|
|
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug C1D2 (n=12)
|
0.20 ng/mL
Standard Deviation 0.00
|
|
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug C1D15 (n=18)
|
73.81 ng/mL
Standard Deviation 29.00
|
|
Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
Total drug 21D1 (n=11)
|
9.87 ng/mL
Standard Deviation 8.36
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdosePopulation: Evaluable set of subjects for PK analysis
Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=10 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters
C1D1
|
0.70 hours
Interval 0.5 to 1.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters
C2D1
|
0.77 hours
Interval 0.5 to 1.0
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=10 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters
C1D1
|
2932.00 ng/mL
Standard Deviation 903.952
|
|
Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters
C2D1
|
2955.38 ng/mL
Standard Deviation 853.925
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=10 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters
C1D1
|
2918.09 ng*hr/mL
Standard Deviation 594.227
|
|
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters
C2D1
|
3101.69 ng*hr/mL
Standard Deviation 778.041
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=10 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters
C1D1
|
3167.53 ng*hr.mL
Standard Deviation 658.124
|
|
Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters
C2D1
|
3326.98 ng*hr.mL
Standard Deviation 775.599
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean AUC24\_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=10 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters
C1D1
|
249.45 ng*hr/mL
Standard Deviation 108.911
|
|
Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters
C2D1
|
225.29 ng*hr/mL
Standard Deviation 96.657
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=10 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters
C1D1
|
3159.58 ng*hr/mL
Standard Deviation 675.834
|
|
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters
C2D1
|
3304.48 ng*hr/mL
Standard Deviation 769.011
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdosePopulation: Evaluable set of subjects for PK analysis
Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=9 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters
C1D1
|
22.55 hours
Standard Deviation 5.914
|
|
Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters
C2D1
|
24.88 hours
Standard Deviation 10.651
|
SECONDARY outcome
Timeframe: First dose of study treatment until progressive diseasePopulation: ITT population = all subjects enrolled in study who received at least 1 dose of study medication (SU011248 or docetaxel).
Median time (50 percent \[%\]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=20 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Progression-Free Survival (PFS) Based on Investigator Assessment
|
34.9 weeks
Interval 28.1 to 55.6
|
SECONDARY outcome
Timeframe: First dose of study treatment until at least 4 weeks after confirmed response or partial responsePopulation: ITT; subjects with baseline assessments
Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=20 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment
|
14 participants
Interval 90.9 to
|
SECONDARY outcome
Timeframe: First dose of study treatment until at least 24 weeks on studyPopulation: ITT; subjects with baseline assessments
Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=20 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment
|
17 participants
|
SECONDARY outcome
Timeframe: Start of first confirmed CR or PR to first confirmed progression or deathPopulation: ITT; subgroup of subjects with objective disease response
Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.
Outcome measures
| Measure |
Sunitinib in Combination With Docetaxel
n=14 Participants
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Duration of Tumor Response Based on Investigator Assessment
|
28.7 weeks
Interval 22.7 to 69.6
|
Adverse Events
Sunitinib in Combination With Docetaxel
Serious adverse events
| Measure |
Sunitinib in Combination With Docetaxel
n=22 participants at risk
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
18.2%
4/22
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.5%
1/22
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
2/22
|
|
Gastrointestinal disorders
Stomatitis
|
4.5%
1/22
|
|
General disorders
Fatigue
|
4.5%
1/22
|
|
General disorders
Oedema peripheral
|
4.5%
1/22
|
|
General disorders
Pyrexia
|
4.5%
1/22
|
|
Hepatobiliary disorders
Jaundice
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.5%
1/22
|
|
Nervous system disorders
Cerebral haemorrhage
|
4.5%
1/22
|
|
Nervous system disorders
Headache
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.5%
1/22
|
Other adverse events
| Measure |
Sunitinib in Combination With Docetaxel
n=22 participants at risk
Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic \[PK\] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Neutropenia
|
45.5%
10/22
|
|
Eye disorders
Conjunctivitis
|
9.1%
2/22
|
|
Eye disorders
Lacrimation increased
|
13.6%
3/22
|
|
Eye disorders
Photopsia
|
9.1%
2/22
|
|
Eye disorders
Visual acuity reduced
|
9.1%
2/22
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
2/22
|
|
Gastrointestinal disorders
Abdominal pain upper
|
31.8%
7/22
|
|
Gastrointestinal disorders
Diarrhoea
|
59.1%
13/22
|
|
Gastrointestinal disorders
Dyspepsia
|
31.8%
7/22
|
|
Gastrointestinal disorders
Glossodynia
|
9.1%
2/22
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.1%
2/22
|
|
Gastrointestinal disorders
Nausea
|
50.0%
11/22
|
|
Gastrointestinal disorders
Oral pain
|
13.6%
3/22
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
11/22
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
4/22
|
|
General disorders
Asthenia
|
27.3%
6/22
|
|
General disorders
Chest discomfort
|
13.6%
3/22
|
|
General disorders
Chest pain
|
18.2%
4/22
|
|
General disorders
Face oedema
|
9.1%
2/22
|
|
General disorders
Fatigue
|
45.5%
10/22
|
|
General disorders
Local swelling
|
9.1%
2/22
|
|
General disorders
Mucosal inflammation
|
40.9%
9/22
|
|
General disorders
Oedema peripheral
|
9.1%
2/22
|
|
General disorders
Pain
|
13.6%
3/22
|
|
General disorders
Pyrexia
|
31.8%
7/22
|
|
Infections and infestations
Cystitis
|
9.1%
2/22
|
|
Infections and infestations
Nasopharyngitis
|
27.3%
6/22
|
|
Investigations
Alanine aminotransferase
|
9.1%
2/22
|
|
Investigations
Electrocardiogram QT prolonged
|
9.1%
2/22
|
|
Metabolism and nutrition disorders
Anorexia
|
13.6%
3/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
4/22
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
3/22
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.6%
3/22
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.8%
7/22
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
2/22
|
|
Nervous system disorders
Dizziness
|
18.2%
4/22
|
|
Nervous system disorders
Dysgeusia
|
27.3%
6/22
|
|
Nervous system disorders
Headache
|
36.4%
8/22
|
|
Nervous system disorders
Paraesthesia
|
9.1%
2/22
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.7%
5/22
|
|
Psychiatric disorders
Depression
|
13.6%
3/22
|
|
Psychiatric disorders
Insomnia
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
4/22
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
27.3%
6/22
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
31.8%
7/22
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
54.5%
12/22
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
50.0%
11/22
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
13.6%
3/22
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.7%
5/22
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.1%
2/22
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
13.6%
3/22
|
|
Vascular disorders
Flushing
|
9.1%
2/22
|
|
Vascular disorders
Hypertension
|
9.1%
2/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER