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Trial · NCT04607772

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryPhase 1: Maximum Tolerated Dose (MTD)Within the first cycle (maximum 28 days) of treatment
PrimaryPhase 1: Recommended Phase 2 Dose (RP2D)Up to 6 cycles (up to 6 months) of treatment
PrimaryPhase 2: Overall Response Rate (ORR) per the Lugano Classification 2014Cycle 1 Day 1 (each cycle consists of maximum 28 days) until a complete response (CR) or partial response (PR) (up to 6 months)
SecondaryPhase 1: Overall Response Rate per the Lugano Classification 2014Cycle 1 Day 1 (each cycle consists of maximum 28 days) until a complete response (CR) or partial response (PR) (up to 6 months)
SecondaryPhase 1: Disease Control Rate (DCR) per Lugano Classification 2014Cycle 1 Day 1 (each cycle consists of maximum 28 days) until a CR or PR or stable disease (SD) (up to 6 months)
SecondaryPhase 1: Duration of Response (DOR) per Lugano Classification 2014Time from the first response of PR or CR until disease progression (up to 12 months)
SecondaryPhase 1: Overall Response Rate (ORR) per the Modified Lugano ClassificationCycle 1 Day 1 (each cycle consists of maximum 28 days) until a CR or PR (up to 6 months)
SecondaryPhase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and SeverityFrom start of study drug administration up to 30 days after last dose of study treatment (up to 24 months)
SecondaryPhase 2: Overall Response Rate per the Modified Lugano ClassificationCycle 1 Day 1 (each cycle consists of maximum 28 days) until a complete response (CR) or partial response (PR) (up to 6 months)
SecondaryPhase 2: Disease Control Rate (DCR) per Lugano Classification 2014Cycle 1 Day 1 (each cycle consists of maximum 28 days) until a CR or PR or stable disease (SD) (up to 6 months)
SecondaryPhase 2: Duration of Response (DOR) per Lugano Classification 2014Time from the first response of PR or CR until disease progression or death (up to 12 months)
SecondaryPhase 2: Number of Participants With AEs by Occurrence, Nature, and SeverityFrom start of study drug administration up to 30 days after last dose of study treatment (up 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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