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Trial · NCT02187848

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of dose limiting adverse events (every 2 week cycle)4 weeks
PrimaryAssessment of overall response rate using standard imaging and RECIST 1.1 criteriaUp to 40 months
PrimaryNumber of dose limiting adverse events (every 3 week cycle)3 weeks
SecondaryNumber of treatment emergent adverse eventsUp to 4 years
SecondaryMaximum concentration (Cmax)2 months
SecondaryTime to reach maximum concentration (tmax)2 months
SecondaryTrough plasma concentrations (Ctrough)Intensive testing within first 2 months, then every 2 weeks
SecondaryArea under the plasma concentration versus time curve between 0 and 14 days (AUC0-14day) for Q2W or between 0 and 21 days (AUC-21 day) for Q3W2 months
SecondaryMean systemic clearance (CL)2 months
SecondaryClearance at steady state (CLss)2 months
SecondaryAccumulation ratio (Rac) on AUC0-14day and Cmax2 months
SecondaryDetection of the development of anti-SAR408701 antibodyUp to 40 months
SecondaryDuration of responseUp to 40 months - assessment every 6-8 weeks
SecondaryTime to ProgressionUp to 40 months - assessment every 6-8 weeks

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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