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Trial · NCT00664326

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYObjective Tumor ResponseFrom start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksEvaluable for response (Primary analysis population)Percentage of participantsNUMBER
PRIMARYTumor ResponseFrom start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksEvaluable for response (Primary analysis population)Percentage of participantsNUMBER
SECONDARYDisease ControlFrom start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksEvaluable for response (Primary analysis population)Percentage of participantsNUMBER
SECONDARYOverall SurvivalFrom start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).intention-to-treat (ITT)DaysMEDIAN
SECONDARYProgression-free Survival (PFS)From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksintention-to-treat (ITT)DaysMEDIAN
SECONDARYTime to Progression (TTP)From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksintention-to-treat (ITT)DaysMEDIAN
SECONDARYDuration of ResponseFrom start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksOnly subjects from ITT population with a response of CR or PR were included in this evaluation.DaysMEDIAN
SECONDARYDuration of Stable Disease (SD)From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeksSubjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.DaysMEDIAN
OTHER_PRE_SPECIFIEDObjective Tumor Response (Update)From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksEvaluable for response (Primary analysis population)Percentage of participantsNUMBER
OTHER_PRE_SPECIFIEDTumor Response (Update)From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksEvaluable for response (Primary analysis population)Percentage of participantsNUMBER
OTHER_PRE_SPECIFIEDDisease Control (Update)From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksEvaluable for response (Primary analysis population)Percentage of participantsNUMBER
OTHER_PRE_SPECIFIEDOverall Survival (Update)From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).intention-to-treat (ITT)DaysMEDIAN
OTHER_PRE_SPECIFIEDProgression-free Survival (Update)From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksintention-to-treat (ITT)DaysMEDIAN
OTHER_PRE_SPECIFIEDTime to Progression (Update)From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksintention-to-treat (ITT)DaysMEDIAN
OTHER_PRE_SPECIFIEDDuration of Response (Update)From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksOnly subjects from ITT population with a response of CR or PR were included in this evaluation.DaysMEDIAN
OTHER_PRE_SPECIFIEDDuration of Stable Disease (Update)From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeksSubjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.DaysMEDIAN

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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