A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00732992

First received: August 8, 2008

Last updated: March 15, 2011

Last verified: March 2011

History of Changes

Results First Received: October 27, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Neoplasm, Malignant
Intervention:	Drug: Sunitinib, Pemetrexed

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

Description

Sunitinib 37.5 mg/Day Continuous Daily Dosing

Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Sunitinib 50 mg/Day Schedule-2/1

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Participant Flow: Overall Study

	Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 50 mg/Day Schedule-2/1
STARTED	6	6
COMPLETED	0	0
NOT COMPLETED	6	6
Adverse Event	1	1
Objective Progression or Relapse	3	5
Global Deterioration of Health Status	1	0
Withdrawal by Subject	1	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

Description

Sunitinib 37.5 mg/Day Continuous Daily Dosing

Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Sunitinib 50 mg/Day Schedule-2/1

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Total

Total of all reporting groups

Baseline Measures

	Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 50 mg/Day Schedule-2/1	Total
Number of Participants [units: participants]	6	6	12
Age, Customized [units: Participants]
20-44 years	0	0	0
45- 64 years	4	2	6
>=65 years	2	4	6
Gender [units: Participants]
Female	0	2	2
Male	6	4	10
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[1] [units: Participants]
Score 0	2	4	6
Score 1	4	2	6

[1]	Score 0: Fully active, able to carry on all pre-disease performance without restriction; Score 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light house work and office work.

Outcome Measures

Hide All Outcome Measures

1. Primary:

Number of Participants With Adverse Events [ Time Frame: End of study (up to individual discontinuation) ]

Measure Type	Primary
Measure Title	Number of Participants With Adverse Events
Measure Description	Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.
Time Frame	End of study (up to individual discontinuation)
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who received at least 1 dose of the study drug.

Reporting Groups

Description

Sunitinib 37.5 mg/Day Continuous Daily Dosing

Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Sunitinib 50 mg/Day Schedule-2/1

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 50 mg/Day Schedule-2/1
Number of Participants Analyzed [units: participants]	6	6
Number of Participants With Adverse Events [units: Participants]
Any adverse events	6	6
Any dose limiting toxicities	0	0
Any serious adverse events	2	1
Any Grade-3 or -4 adverse events	6	3
Any Grade-5 adverse events (= death)	0	0
Discontinuation due to adverse events	1	1

No statistical analysis provided for Number of Participants With Adverse Events

2. Secondary:

Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm [ Time Frame: Up to Cycle 5 (end of study) ]

Measure Type	Secondary
Measure Title	Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm
Measure Description	Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.
Time Frame	Up to Cycle 5 (end of study)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set = defined as "all enrolled patients". n = number of participants assessed for the relative dose intensity in the given period.

Reporting Groups

	Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing
Number of Participants Analyzed [units: participants]	6
Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm [units: percent of total planned dose] Median ( Full Range )
Cycle 1 (n=6)	92.0 ( 75.9 to 100 )
Cycle 2 (n=6)	54.8 ( 4.8 to 100 )
Cycle 3 (n=4)	46.0 ( 14.9 to 95.2 )
Cycle 4 (n=4)	55.6 ( 41.4 to 104.8 )
Cycle 5 (n=1)	44.4 ( 44.4 to 44.4 )

No statistical analysis provided for Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm

3. Secondary:

Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm [ Time Frame: Up to Cycle 6 ]

Measure Type	Secondary
Measure Title	Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm
Measure Description	Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.
Time Frame	Up to Cycle 6
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set = defined as "all enrolled patients". n = number of participants assessed for the relative dose intensity in the given period.

Reporting Groups

	Description
Sunitinib 50 mg/Day Schedule-2/1	Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Description

Sunitinib 50 mg/Day Schedule-2/1

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 50 mg/Day Schedule-2/1
Number of Participants Analyzed [units: participants]	6
Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm [units: percent of total planned dose] Median ( Full Range )
Cycle 1 (n=6)	87.5 ( 60 to 100 )
Cycle 2 (n=5)	80.4 ( 38.4 to 100 )
Cycle 3 (n=4)	53.6 ( 42.9 to 75 )
Cycle 4 (n=3)	50.0 ( 50 to 75 )
Cycle 5 (n=3)	50.0 ( 41.1 to 50 )
Cycle 6 (n=3)	50.0 ( 50 to 50 )

No statistical analysis provided for Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm

4. Secondary:

Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [ Time Frame: Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose ]

Measure Type	Secondary
Measure Title	Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1
Measure Description	Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.
Time Frame	Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who provided a plasma concentration data was included in the analysis.

Reporting Groups

	Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing
Number of Participants Analyzed [units: participants]	3
Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [units: nanogram/mL] Mean ± Standard Deviation
Sunitinib: Trough concentration	45.6 ± 11.7
Sunitinib: Maximum concentration	59.9 ± 10.9
SU012662: Trough concentration	25.1 ± 5.08
SU012662: Maximum concentration	31.6 ± 5.49
Total drug: Trough concentration	70.6 ± 13.9
Total drug: Maximum concentration	91.5 ± 14.2

No statistical analysis provided for Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

5. Secondary:

AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [ Time Frame: Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose ]

Measure Type	Secondary
Measure Title	AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1
Measure Description	AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib.
Time Frame	Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who provided a plasma concentration data was included in the analysis.

Reporting Groups

	Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing
Number of Participants Analyzed [units: participants]	3
AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [units: nanogram*hour/mL] Mean ± Standard Deviation
Sunitinib	1190 ± 247
SU012662	675 ± 107
Total Drug	1866 ± 269

No statistical analysis provided for AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

6. Secondary:

Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [ Time Frame: Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose ]

Measure Type	Secondary
Measure Title	Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1
Measure Description	Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib.
Time Frame	Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who provided a plasma concentration data was included in the analysis.

Reporting Groups

	Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing
Number of Participants Analyzed [units: participants]	3
Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [units: hours] Median ( Full Range )
Sunitinib	4 ( 4 to 6 )
SU012662	4 ( 4 to 6 )
Total Drug	4 ( 4 to 6 )

No statistical analysis provided for Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

7. Secondary:

Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [ Time Frame: Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

Measure Type	Secondary
Measure Title	Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1
Measure Description	No text entered.
Time Frame	Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who provided a plasma concentration data was included in the analysis.

Reporting Groups

	Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing
Number of Participants Analyzed [units: participants]	3
Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [units: microgram/mL] Mean ± Standard Deviation	163 ± 30.7

No statistical analysis provided for Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

8. Secondary:

AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [ Time Frame: Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

Measure Type	Secondary
Measure Title	AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1
Measure Description	AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct/kel), where Ct was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.
Time Frame	Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who provided a plasma concentration data was included in the analysis.

Reporting Groups

	Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing
Number of Participants Analyzed [units: participants]	3
AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [units: microgram*hour/mL] Mean ± Standard Deviation	191 ± 36.3

No statistical analysis provided for AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

9. Secondary:

Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [ Time Frame: Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

Measure Type	Secondary
Measure Title	Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1
Measure Description	Terminal phase elimination half-life was calculated as "natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)".
Time Frame	Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who provided a plasma concentration data was included in the analysis.

Reporting Groups

	Description
Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing
Number of Participants Analyzed [units: participants]	3
Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1 [units: hours] Mean ± Standard Deviation	2.754 ± 0.531

No statistical analysis provided for Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

10. Secondary:

Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15 [ Time Frame: Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose ]

Measure Type	Secondary
Measure Title	Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15
Measure Description	Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.
Time Frame	Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who provided a plasma concentration data was included in the analysis

Reporting Groups

Description

Sunitinib 50 mg/Day Schedule-2/1

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 50 mg/Day Schedule-2/1
Number of Participants Analyzed [units: participants]	6
Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15 [units: nanogram/mL] Mean ± Standard Deviation
Sunitinib	78.5 ± 22.2
SU012662	38.2 ± 17.0
Total Drug	117 ± 30.8

No statistical analysis provided for Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15

11. Secondary:

Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants [ Time Frame: End of study (Up to individual study discontinuation) ]

Measure Type	Secondary
Measure Title	Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants
Measure Description	Complete response (CR): disappearance of all target lesions; Partial response (PR): >=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): >=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of >=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started.
Time Frame	End of study (Up to individual study discontinuation)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable subjects = defined as all subjects who met all the following 3 requirements: 1) met the eligibility (inclusion and exclusion) criteria, 2) received at least 1 dose of the study drug, and 3) assessed appropriately at the baseline and had a measurable lesion based on the RECIST.

Reporting Groups

Description

Sunitinib 37.5 mg/Day Continuous Daily Dosing

Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Sunitinib 50 mg/Day Schedule-2/1

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Measured Values

	Sunitinib 37.5 mg/Day Continuous Daily Dosing	Sunitinib 50 mg/Day Schedule-2/1
Number of Participants Analyzed [units: participants]	4	4
Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants [units: Participants]
Complete Response (CR)	0	0
Partial Response (PR)	1	0
Stable Disease (SD)	2	3
Progressive Disease (PD)	1	1
Not Evaluable (NE)	0	0
Objective Response (CR+PR)	1	0
Stable Disease (SD) >=184 days	0	1
Clinical Benefit (CR+PR+SD >=184 days)	1	1

No statistical analysis provided for Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided by Pfizer

Publications automatically indexed to this study:

Okamoto I, Shimizu T, Miyazaki M, Tsurutani J, Ichikawa Y, Terashima M, Takeda M, Fumita S, Ohki E, Kimura N, Hashimoto J, Nakagawa K. Feasibility study of two schedules of sunitinib in combination with pemetrexed in patients with advanced solid tumors. Invest New Drugs. 2012 Apr;30(2):639-46. Epub 2010 Oct 20.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00732992 History of Changes
Other Study ID Numbers:	A6181165
Study First Received:	August 8, 2008
Results First Received:	October 27, 2010
Last Updated:	March 15, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

To Top