Neoplasm, Malignant Clinical Trial
Official title:
Phase 1 Study Of Sunitinib (SU011248) In Combination With Pemetrexed In Patients With Advanced Solid Malignancies In Japan
| Verified date | March 2011 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
| Study type | Interventional |
This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.
| 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Pfizer Investigational Site | Osakasayama-shi | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Japan,
| 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 |