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Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00553696
First received: November 2, 2007
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasms
Drug: Cisplatin
Drug: S-1
Drug: Sunitinib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • first cycle dose limiting toxicity (DLT) [ Time Frame: first cycle dose limiting toxicity (DLT) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics parameters on Sunitinib, S-1 and Cisplatin during 1-4 cycles. [ Time Frame: during 1-4 cycles ] [ Designated as safety issue: Yes ]
  • PFS, TTP and ORR throughout the treatment period (12 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety profile throughout the treatment period (12 months). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: November 2007
Study Completion Date: March 2014
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Cisplatin
Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
Drug: S-1
S-1 80 mg/m2 on days 1-21 of each 28 day cycle
Drug: Sunitinib
Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553696

Locations
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Saku, Nagano, Japan
Pfizer Investigational Site
Suntougun, Shizuoka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00553696     History of Changes
Other Study ID Numbers: A6181127
Study First Received: November 2, 2007
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
chemotherapy
combination

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Cisplatin
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014