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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

November 2, 2007
March 6, 2014
November 2007
July 2009   (final data collection date for primary outcome measure)
first cycle dose limiting toxicity (DLT) [ Time Frame: first cycle dose limiting toxicity (DLT) ] [ Designated as safety issue: Yes ]
first cycle dose limiting toxicity (DLT)
Complete list of historical versions of study NCT00553696 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety profile throughout the treatment period (12 months).
  • Pharmacokinetics parameters on Sunitinib, S-1 and Cisplatin during 1-4 cycles.
  • PFS, TTP and ORR throughout the treatment period (12 months)
Not Provided
Not Provided
 
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
A Phase I Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
  • 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
Experimental: A
Interventions:
  • Drug: Cisplatin
  • Drug: S-1
  • Drug: Sunitinib
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.
 
Completed
27
March 2014
July 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00553696
A6181127
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP