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Trial · NCT07318883

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryORR assessed by BICR (part I)Assessed up to appoximately 6 months from enrollmentDefined as the proportion of participants who achieve a best overall response of CR or PR
PrimaryPFS assessed by BICR (part I)Assessed up to appoximately 16 months from enrollmentDefined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)
PrimaryPFS assessed by BICR (part II)Assessed up to appoximately 23 months from enrollmentDefined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)
PrimaryOS (part II)Assessed up to appoximately 42 months from enrollmentDefined as the time from randomization to death due to any cause
SecondaryDCR (part I)Assessed up to appoximately 6 months from enrollmentDefined as the proportion of participants who achieve a best overall response of CR or PR or an SD
SecondaryOS (part I)Assessed up to appoximately 35 months from enrollmentDefined as the time from randomization to death due to any cause
SecondaryDOR (part I)Assessed up to appoximately 35 months from enrollmentDefined as the time from the first documented objective response to PD or death
SecondaryORR assessed by investigator (part I)Assessed up to appoximately 6 months from enrollmentDefined as the proportion of participants who achieve a best overall response of CR or PR
SecondaryPFS assessed by investigator (part I)Assessed up to appoximately 16 months from enrollmentDefined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)
SecondaryIncidence of adverse events (part I)Assessed up to appoximately 35 months from enrollment
SecondaryORR (part II)Assessed up to appoximately 6 months from enrollmentDefined as the proportion of participants who achieve a best overall response of CR or PR
SecondaryDCR (part II)Assessed up to appoximately 6 months from enrollmentdefined as the proportion of participants who achieve a best overall response of CR or PR or an SD lasting for 12 weeks
SecondaryDOR (part II)Assessed up to appoximately 42 months from enrollmentDefined as the time from the first documented objective response to PD or death
SecondaryPFS assessed by investigator (part II)Assessed up to appoximately 23 months from enrollmentDefined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first)
SecondaryIncidence of adverse events (part II)Assessed up to appoximately 42 months from enrollment

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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GET https://conductscience.org/api/trials/v1/NCT07318883/registered