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Trial · NCT00553696

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)Sunitinib 25 mg CDD + S-1 + Cisplatin2participants
Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)Sunitinib 25 mg 2/2 + S-1 + Cisplatin (Dose Escalation Cohort)1participants
Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin3participants
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)14.47Standard Deviation 5.3414nanogram 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)13.14Standard Deviation 3.1675nanogram 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)2.487Standard Deviation 1.1515nanogram 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)2.331Standard Deviation 1.2943nanogram 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)16.86Standard Deviation 6.3194nanogram 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)15.41Standard Deviation 3.7667nanogram 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)5.97Full Range 3.83 to 8.00hrs
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 2 Day 1: Sunitinib (Sunitinib+S-1+Cisplatin)7.97Full Range 3.97 to 9.93hrs
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: SU-012662 ( Sunitinib Alone)8.00Full Range 3.83 to 10.1hrs
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 2 Day 1: SU-012662 (Sunitinib+S-1+Cisplatin)9.25Full Range 5.97 to 23.8hrs
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)Cycle1 Day1:Total Drug ( Sunitinib Alone)5.97Full Range 3.83 to 9.22hrs
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 2 Day 1:Total Drug (Sunitinib+S-1+Cisplatin)7.92Full Range 3.97 to 9.25hrs
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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)214.6Standard Deviation 61.682ng*h/mL
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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)211.9Standard Deviation 46.092ng*h/mL
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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)39.77Standard Deviation 12.857ng*h/mL
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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)44.83Standard Deviation 24.046ng*h/mL
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 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: Total Drug (Sunitinib Alone)254.4Standard Deviation 70.913ng*h/mL

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.

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