A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer

Pfizer3 sites in 1 country27 target enrollmentNovember 2007

ConditionsStomach Neoplasms

InterventionsCisplatin S-1 Sunitinib

DrugsCisplatin S-1 Sunitinib

Overview

Phase: Phase 1
Intervention: Cisplatin
Conditions: Stomach Neoplasms
Sponsor: Pfizer
Enrollment: 27
Locations: 3
Primary Endpoint: Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

March 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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

Arms & Interventions

A

Intervention: Cisplatin

A

Intervention: S-1

A

Intervention: Sunitinib

Outcomes

Primary Outcomes

Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)

Time Frame: Cycle 1 (Baseline to Week 4)

A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).

Secondary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)(Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose))
Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU(Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose))
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)(Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose))
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU(Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose))
Progression-Free Survival (PFS)(Baseline up to 739 days)
Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)(Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose))
Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum(Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion))
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum(Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion))
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU(Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose))
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum(Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion))
Number of Participants With Objective Response(Baseline up to 739 days)
Number of Participants With Clinical Benefit Response (CBR)(Baseline up to 739 days)
Duration of Response (DR)(Baseline up to 739 days)
Time to Progression (TTP)(Baseline up to 739 days)