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Trial · NCT04852679

Outcomes12

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYClinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24The ITT analysis set included all participants who received at least 1 dose of study intervention.percentage of participantsNUMBER
SECONDARYProgression Free Survival (PFS) by BICR Within Weeks 24 and 48RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.weeksMEDIAN
SECONDARYOverall Survival (OS) at the End of the Main Intervention PeriodRECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period)The ITT analysis set included all participants who received at least 1 dose of study intervention.weeksMEDIAN
SECONDARYTime to Progression (TTP) During Main Intervention PeriodRECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.weeksMEDIAN
SECONDARYPercentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.percentage of participantsNUMBER
SECONDARYClinical Benefit Rate Assessed by BICR at Week 48RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48The ITT analysis set included all participants who received at least 1 dose of study intervention.percentage of participantsNUMBER
SECONDARYOverall Response Rate (ORR) at Weeks 24 and 48RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.percentage of participantsNUMBER
SECONDARYDisease Control Rate (DCR) at Weeks 24 and 48RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.percentage of participantsNUMBER
SECONDARYNumber of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48Weeks 24 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.microgram per literMEAN
SECONDARYChange From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.milligram per literMEAN
SECONDARYChange From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48The ITT analysis set included all participants who received at least 1 dose of study intervention.units on a scaleMEAN

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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