Phase 1
Completed N=12
A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies
Neoplasm, Malignant
Source: ClinicalTrials.gov NCT00732992 ↗
Enrolled (actual)
12
Serious AEs
25.0%
Results posted
Nov 2010
Primary outcomePrimary: Number of Participants With Adverse Events — 6; 6; 0; 0 Participants
Summary
This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
6; 6; 0; 0; 2; 1 | — |
| SECONDARY Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm |
92.0; 54.8; 46.0; 55.6; 44.4 | — |
| SECONDARY Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm |
87.5; 80.4; 53.6; 50.0; 50.0; 50.0 | — |
| 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 |
45.6; 59.9; 25.1; 31.6; 70.6; 91.5 | — |
| 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 |
1190; 675; 1866 | — |
| 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 |
4; 4; 4 | — |
| 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 |
163 | — |
| 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 |
191 | — |
| 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 |
2.754 | — |
| 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 |
78.5; 38.2; 117 | — |
| SECONDARY Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants |
0; 0; 1; 0; 2; 3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00732992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.