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 3, 2015
Last verified: March 2015
Results First Received: March 3, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stomach Neoplasms
Interventions: Drug: Cisplatin
Drug: S-1
Drug: Sunitinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three to 6 participants at each dose regimen were to be initially assessed for dose limiting toxicity (dose escalation cohort) and 10 participants were added to the maximum tolerated dose (MTD) group after MTD was determined at Sunitinib 25 mg once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2) regimen (MTD expansion cohort).

Reporting Groups
  Description
Sunitinib 25 mg CDD + S-1 + Cisplatin Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
Sunitinib 12.5 mg CDD + S-1 + Cisplatin Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.

Participant Flow:   Overall Study
    Sunitinib 25 mg CDD + S-1 + Cisplatin     Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)     Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin     Sunitinib 12.5 mg CDD + S-1 + Cisplatin  
STARTED     4     16     6     1  
COMPLETED     0     0     0     0  
NOT COMPLETED     4     16     6     1  
Adverse Event                 2                 4                 0                 1  
Global deterioration of health status                 0                 2                 0                 0  
Objective progression or relapse                 2                 9                 6                 0  
Withdrawal by Subject                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sunitinib 25 mg CDD + S-1 + Cisplatin Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
Sunitinib 12.5 mg CDD + S-1 + Cisplatin Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
Total Total of all reporting groups

Baseline Measures
    Sunitinib 25 mg CDD + S-1 + Cisplatin     Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)     Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin     Sunitinib 12.5 mg CDD + S-1 + Cisplatin     Total  
Number of Participants  
[units: participants]
  4     16     6     1     27  
Age  
[units: years]
Mean ± Standard Deviation
  60.8  ± 12.8     56.8  ± 11.4     54.8  ± 16.6     64  ± 0     57.2  ± 12.3  
Gender  
[units: Participants]
         
Female     2     3     2     1     8  
Male     2     13     4     0     19  



  Outcome Measures
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1.  Primary:   Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)   [ Time Frame: Cycle 1 (Baseline to Week 4) ]

2.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) ]

3.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) ]

4.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) ]

5.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) ]

6.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) ]

7.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) ]

8.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) ]

9.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) ]

10.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum   [ Time Frame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) ]

11.  Secondary:   Number of Participants With Objective Response   [ Time Frame: Baseline up to 739 days ]

12.  Secondary:   Number of Participants With Clinical Benefit Response (CBR)   [ Time Frame: Baseline up to 739 days ]

13.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline up to 739 days ]

14.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline up to 739 days ]

15.  Secondary:   Time to Progression (TTP)   [ Time Frame: Baseline up to 739 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00553696     History of Changes
Other Study ID Numbers: A6181127
Study First Received: November 2, 2007
Results First Received: March 3, 2015
Last Updated: March 3, 2015
Health Authority: United States: Food and Drug Administration