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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00732992
Other study ID # A6181165
Secondary ID
Status Completed
Phase Phase 1
First received August 8, 2008
Last updated March 15, 2011
Start date August 2008
Est. completion date November 2009

Study information

Verified date March 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients with a diagnosis of a solid malignancy that is refractory to standard therapy or for which no standard therapy exists.

- Patients has a good performance status (ECOG 0 or 1)

Exclusion Criteria:

- Prior treatment with either pemetrexed or SU011248.

- Coughing up blood within 4 weeks before starting study treatment (small amounts okey).

- Hypertension that cannot be controlled by medications.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Sunitinib, Pemetrexed
Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity.
Sunitinib, Pemetrexed
Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable toxicity.

Locations

Country Name City State
Japan Pfizer Investigational Site Osakasayama-shi Osaka

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events 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. End of study (up to individual discontinuation) Yes
Secondary Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period. Up to Cycle 5 (end of study) No
Secondary Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period. Up to Cycle 6 No
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 Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib. Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose No
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 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. Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose No
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 Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib. Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose No
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 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 No
Secondary AUC0-8 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 AUC0-8 = 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. 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 No
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 Terminal phase elimination half-life was calculated as "natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)". 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 No
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 Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib. Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose No
Secondary Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants 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. End of study (Up to individual study discontinuation) No