Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin 60 mg/m2 on day 1 of each 28 day cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Cycle 1 (Baseline to Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi cancer center central hospital / Medical Oncology | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Saku Central Hospital, GI Devision |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23665950 | Derived | 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. |
Not provided
Not provided
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).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | DLT Evaluation Set consisted of participants who were initially enrolled for the determination of maximam tolerated dose (MTD), and either 'experienced DLT' or 'received all of the Day 1 chemotherapy, received at least 80% of their sunitinib doses, and at least 80% of S-1 doses'. | Posted | Number | participants | Cycle 1 (Baseline to Week 4) |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C079198 | S 1 (combination) |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| S-1 |
| Drug |
S-1 80 mg/m2 on days 1-21 of each 28 day cycle |
|
| Sunitinib | Drug | 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 |
|
| Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) |
| 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) | Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) |
| Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU | Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU | Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) |
| 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) | Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) |
| Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum | Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum | Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) |
| 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) | Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) |
| 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. | Baseline up to 739 days |
| 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. | Baseline up to 739 days |
| 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). | Baseline up to 739 days |
| 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) | Baseline up to 739 days |
| 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). | Baseline up to 739 days |
| Saku |
| Nagano |
| Japan |
| Shizuoka Cancer Center | Suntougun | Shizuoka | 411-8777 | Japan |
| Global deterioration of health status |
|
| Objective progression or relapse |
|
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (Dose Escalation Cohort) | 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 regimen 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. |
| OG002 | 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. |
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Median | Full Range | hrs | Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) |
|
|
|
| Secondary | 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) | Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Mean | Standard Deviation | ng*h/mL | Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose) |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU | Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU | Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Median | Full Range | hrs | Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) |
|
|
|
| Secondary | 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) | Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Mean | Standard Deviation | ng*h/mL | Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum | Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum | Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Median | Full Range | hrs | Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) |
|
|
|
| Secondary | 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) | Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | Posted | Mean | Standard Deviation | ng*h/mL | Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion) |
|
|
|
| Secondary | 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. | Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib) | Posted | Number | participants | Baseline up to 739 days |
|
|
|
| Secondary | 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. | Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib). | Posted | Number | participants | Baseline up to 739 days |
|
|
|
| Secondary | 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). | A subgroup of participants with an objective tumor response among Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib) | Posted | Median | 95% Confidence Interval | Months | Baseline up to 739 days |
|
|
|
| Secondary | 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) | Full Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib). | Posted | Median | 95% Confidence Interval | Months | Baseline up to 739 days |
|
|
|
| Secondary | 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 Analysis Set consisted of all participants enrolled in the study who received at least 1 dose of study medication (cisplatin, S-1 or sunitinib). | Posted | Median | 95% Confidence Interval | Months | Baseline up to 739 days |
|
|
|
| 2 |
| 4 |
| 4 |
| 4 |
| EG001 | 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. | 8 | 16 | 16 | 16 |
| EG002 | 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. | 2 | 6 | 6 | 6 |
| EG003 | 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. | 1 | 1 | 1 | 1 |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Extravasation | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase abnormal | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood calcium | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| Cycle 2 Day 1:SU-012662(Sunitinib+S-1+Cisplatin) |
|
| Cycle1 Day 1:Total Drug (Sunitinib Alone) |
|
| Cycle 2 Day 1:Total Drug(Sunitinib+S-1+Cisplatin) |
|
|
| Cycle 2 Day 1: SU-012662 (Sunitinib+S-1+Cisplatin) |
|
| Cycle1 Day1:Total Drug ( Sunitinib Alone) |
|
| Cycle 2 Day 1:Total Drug (Sunitinib+S-1+Cisplatin) |
|
|
| Cycle 2 Day 1: SU-012662 (Sunitinib+S-1+Cisplatin) |
|
| Cycle 1 Day 1: Total Drug (Sunitinib Alone) |
|
| Cycle 2 Day 1:Total Drug (Sunitinib+S-1+Cisplatin) |
|
|
| Cycle 2 Day 1: 5-FU (Sunitinib+S-1+Cisplatin) |
|
|
| Cycle 2 Day 1: 5-FU (Sunitinib+S-1+Cisplatin) |
|
|
| Cycle 2 Day 1: 5-FU (Sunitinib+S-1+Cisplatin) |
|
|
| Cycle 2 Day 1:Free (Sunitinib+S-1+Cisplatin) |
|
|
| Cycle 2 Day 1:Free (Sunitinib+S-1+Cisplatin) |
|
|
| Cycle 2 Day 1:Free (Sunitinib+S-1+Cisplatin) |
|