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


Phase 1
18 Years
N/A
Not Enrolling
Both
Stomach Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

The incidence of DLTs assessed during the first cycle (21 days).

Outcome Time Frame:

Cycle 1 (Baseline to Day 21)

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181128

NCT ID:

NCT00555672

Start Date:

August 2008

Completion Date:

August 2010

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms

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