Trial · NCT00553696
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| SECONDARY | Number of Participants With Objective Response | Baseline up to 739 days | 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) | participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Benefit Response (CBR) | Baseline up to 739 days | 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). | participants | NUMBER |
| SECONDARY | Duration of Response (DR) | Baseline up to 739 days | 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) | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Baseline up to 739 days | 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). | Months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | Baseline up to 739 days | 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). | Months | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT00553696/outcomes