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Trial · NCT03449381

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryPhase Ia- Maximum tolerated dose (MTD) based on number of patients with dose limiting toxicities (DLTs) during first treatment cycleUp to 28 days
PrimaryPhase Ib - Progression-free survivalUp to 24 months
PrimaryPhase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B)Up to 28 days
PrimaryPhase Ib - Number of patients with DLTs during the first treatment cycleUp to 28 days
SecondaryPhase Ia - Cmax: Maximum measured concentration of BI 907828 in plasmaUp to 24 months
SecondaryPhase Ia - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinityUp to 24 months
SecondaryPhase Ib - Objective responseUp to 24 months
SecondaryPhase Ib - Overall survivalUp to 24 months
SecondaryPhase Ib - Number of patients with Grade ≥3 treatment-related adverse events observed during the entire treatment periodUp to 24 months
SecondaryPhase Ib - Cmax: Maximum measured concentration of BI 907828 in plasmaUp to 24 months
SecondaryPhase Ib - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinityUp to 24 months

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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