Back to resultsStudy Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Cisplatin
S-1
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring chemotherapy, combination
Eligibility 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
Sites / Locations
- Aichi cancer center central hospital / Medical Oncology
- Saku Central Hospital, GI Devision
- Shizuoka Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)
A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Number of Participants With Objective Response
Number of participants with objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.
Number of Participants With Clinical Benefit Response (CBR)
CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.
Duration of Response (DR)
Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).
Progression-Free Survival (PFS)
Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)
Time to Progression (TTP)
Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00553696
Brief Title
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
Official Title
A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
chemotherapy, combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1 80 mg/m2 on days 1-21 of each 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)
Description
A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).
Time Frame
Cycle 1 (Baseline to Week 4)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)
Title
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)
Title
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)
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)
Title
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)
Title
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)
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)
Title
Number of Participants With Objective Response
Description
Number of participants with objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.
Time Frame
Baseline up to 739 days
Title
Number of Participants With Clinical Benefit Response (CBR)
Description
CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.
Time Frame
Baseline up to 739 days
Title
Duration of Response (DR)
Description
Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).
Time Frame
Baseline up to 739 days
Title
Progression-Free Survival (PFS)
Description
Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)
Time Frame
Baseline up to 739 days
Title
Time to Progression (TTP)
Description
Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).
Time Frame
Baseline up to 739 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Aichi cancer center central hospital / Medical Oncology
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Saku Central Hospital, GI Devision
City
Saku
State/Province
Nagano
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Suntougun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23665950
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181127&StudyName=Study%20Of%20Sunitinib%20With%20S-1%20And%20Cisplatin%20For%20Gastric%20Cancer
Description
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Learn more about this trial
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
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