Phase 1
Completed N=27
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
Source: ClinicalTrials.gov NCT00553696 ↗Enrolled (actual)
27
Serious AEs
48.2%
Results posted
Mar 2015
Primary outcomePrimary: Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) — 2; 1; 3 participants
Summary
To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) |
2; 1; 3 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) |
14.47; 13.14; 2.487; 2.331; 16.86; 15.41 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) |
5.97; 7.97; 8.00; 9.25; 5.97; 7.92 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) |
214.6; 211.9; 39.77; 44.83; 254.4; 257.0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU |
1500; 1540; 144.4; 105.7 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU |
1.98; 2.00; 2.00; 2.05 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU |
8314; 9182; 582.4; 494.8 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum |
1794; 1984; 177.8; 186.9 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum |
2.65; 2.68; 2.65; 2.68 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum |
29020; 33000; 967.8; 1154 | — |
| SECONDARY Number of Participants With Objective Response |
2; 6; 2; 0 | — |
| SECONDARY Number of Participants With Clinical Benefit Response (CBR) |
2; 12; 4; 0 | — |
| SECONDARY Duration of Response (DR) |
5.7; 10.4; 5.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
7.1; 12.5; 5.8 | — |
| SECONDARY Time to Progression (TTP) |
7.1; 12.5; 5.8 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of gastric cancer
- Chemonaive patients
- Adequate organ function
Exclusion Criteria
- Patients who meet the contra-indications of S-1 and Cisplatin.
- Prior chemotherapy failure patients
Data sourced from ClinicalTrials.gov (NCT00553696). 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.