Trial · NCT00553696
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
NCT00553696, Phase 1, Completed, Pfizer; results first posted 2015-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer. Trials, record NCT00553696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00553696
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
- NCT number
- NCT00553696
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 27 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Stomach Neoplasms
- Interventions
- Cisplatin, S-1, Sunitinib
- First posted
- 2007-11-05
- Last updated
- 2015-03-13
- Results first posted
- 2015-03-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | Cycle 1 (Baseline to Week 4) | 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 | 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) | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) 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) | |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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 plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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 plasma concentration time-curve from zero to the last measured concentration (AUClast) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | Cycle 1 (Baseline to Week 4) | 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'. | participants | NUMBER |
| SECONDARY | 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) | Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) 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) | Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | hrs | MEDIAN |
| SECONDARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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) | Participants who received Sunitinib and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | ng*h/mL | MEAN |
| SECONDARY | 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) | Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | 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) | Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | hrs | MEDIAN |
| SECONDARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU | Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose) | Participants who received S-1 and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | ng*h/mL | MEAN |
| SECONDARY | 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) | Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | 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) | Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | hrs | MEDIAN |
| SECONDARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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) | Participants who received cisplatin and had sufficient plasma concentration data for calculation of pharmacokinetic parameters | ng*h/mL | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | Sunitinib 25 mg CDD + S-1 + Cisplatin | 2 | participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (Dose Escalation Cohort) | 1 | participants | ||
| Number of Participants With First Cycle Dose-limiting Toxicities (DLTs) | Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin | 3 | participants | ||
| Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort) | Cycle 1 Day 1: Sunitinib (Sunitinib Alone) | 14.47 | Standard Deviation 5.3414 | nanogram per milliliter (ng/mL) |
| Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort) | Cycle 2 Day 1:Sunitinib (Sunitinib+S-1+Cisplatin) | 13.14 | Standard Deviation 3.1675 | nanogram per milliliter (ng/mL) |
| Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort) | Cycle 1 Day 1: SU-012662 (Sunitinib Alone) | 2.487 | Standard Deviation 1.1515 | nanogram per milliliter (ng/mL) |
| Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort) | Cycle 2 Day 1:SU-012662(Sunitinib+S-1+Cisplatin) | 2.331 | Standard Deviation 1.2943 | nanogram per milliliter (ng/mL) |
| Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort) | Cycle1 Day 1:Total Drug (Sunitinib Alone) | 16.86 | Standard Deviation 6.3194 | nanogram per milliliter (ng/mL) |
| Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort) | Cycle 2 Day 1:Total Drug(Sunitinib+S-1+Cisplatin) | 15.41 | Standard Deviation 3.7667 | nanogram per milliliter (ng/mL) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662) | Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort) | Cycle 1 Day 1: Sunitinib ( Sunitinib Alone) | 5.97 | Full Range 3.83 to 8.00 | hrs |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib 25 mg CDD + S-1 + Cisplatin | 4 | |
| Overall Study | STARTED | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | 16 | |
| Overall Study | STARTED | Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin | 6 | |
| Overall Study | STARTED | Sunitinib 12.5 mg CDD + S-1 + Cisplatin | 1 | |
| Overall Study | COMPLETED | Sunitinib 25 mg CDD + S-1 + Cisplatin | 0 | |
| Overall Study | COMPLETED | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | 0 | |
| Overall Study | COMPLETED | Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin | 0 | |
| Overall Study | COMPLETED | Sunitinib 12.5 mg CDD + S-1 + Cisplatin | 0 | |
| Overall Study | NOT COMPLETED | Sunitinib 25 mg CDD + S-1 + Cisplatin | 4 | |
| Overall Study | NOT COMPLETED | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events608
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib 25 mg CDD + S-1 + Cisplatin | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | 3 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib 12.5 mg CDD + S-1 + Cisplatin | 1 | 1 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Sunitinib 25 mg CDD + S-1 + Cisplatin | 0 | 4 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | 2 | 16 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin | 0 | 6 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Sunitinib 12.5 mg CDD + S-1 + Cisplatin | 1 | 1 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib 25 mg CDD + S-1 + Cisplatin | 0 | 4 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | 3 | 16 |
1 to 10 of 608Source ClinicalTrials.gov
See all 608 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib 25 mg CDD + S-1 + Cisplatin | ||
| Total, all-cause mortality | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | ||
| Total, all-cause mortality | Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin | ||
| Total, all-cause mortality | Sunitinib 12.5 mg CDD + S-1 + Cisplatin | ||
| Total, other adverse events | Sunitinib 25 mg CDD + S-1 + Cisplatin | 4 | 4 |
| Total, other adverse events | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | 16 | 16 |
| Total, other adverse events | Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin | 6 | 6 |
| Total, other adverse events | Sunitinib 12.5 mg CDD + S-1 + Cisplatin | 1 | 1 |
| Total, serious adverse events | Sunitinib 25 mg CDD + S-1 + Cisplatin | 2 | 4 |
| Total, serious adverse events | Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All) | 8 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23665950 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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