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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Aichi cancer center central hospital / Medical Oncology
Nagoya, Aichi, 464-8681 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stomach Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically or cytologically confirmed diagnosis of gastric cancer

- Chemonaive patients

- Adequate organ function

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients who meet the contra-indications of S-1 and Cisplatin.

- Prior chemotherapy failure patients

NCT00553696
Pfizer
Completed
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer

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Descriptive Information
Brief Title  ICMJE Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
Official Title  ICMJE A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stomach Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: A
Interventions:
  • Drug: Cisplatin
  • Drug: S-1
  • Drug: Sunitinib
Publications *Boku N, Muro K, Machida N, Hashigaki S, Kimura N, Suzuki M, Lechuga M, Miyata Y. Phase I study of sunitinib plus S-1 and cisplatin in Japanese patients with advanced or metastatic gastric cancer. Invest New Drugs. 2014 Apr;32(2):261-70. doi: 10.1007/s10637-013-9948-5. Epub 2013 May 12.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2014)
27
Original Enrollment  ICMJE
 (submitted: November 2, 2007)
30
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion DateJuly 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00553696
Other Study ID Numbers  ICMJE A6181127
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

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