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
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

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

ClinicalTrials.gov processed this record on April 17, 2014