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Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stomach Neoplasms

Intervention: 5-fluorouracil (Drug); cisplatin (Drug); sunitinib malate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.

Clinical Details

Official title: A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)

Secondary outcome:

Maximum Observed Plasma Concentration (Cmax)

Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Steady State Concentration (Css) of 5-Fluorouracil (5-FU)

Infusion Rate (Zero Order) (R0) of 5-FU

Clearance (CLss) of 5-FU

Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU

Number of Participants With Objective Response

Duration of Response (DR)

Progression-Free Survival (PFS)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- confirmed diagnosis of stomach cancer

- advanced stomach cancer stage IV

- adequate blood chemistry, blood counts and kidney function

- willing to participate to study requirements and to sign an informed consent document

Exclusion Criteria:

- prior chemotherapy for stomach cancer in its advanced stage

- excessive toxicities related to prior therapies

- pregnant or breastfeeding patients

Locations and Contacts

Pfizer Investigational Site, Barcelona 08003, Spain

Pfizer Investigational Site, Madrid 28041, Spain

Pfizer Investigational Site, L'hospitalet de Llobregat, Barcelona 08907, Spain

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2008
Last updated: December 12, 2011

Page last updated: August 20, 2015

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