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Trial · NCT02616393

Outcomes11

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYBest Overall Response Rate (ORR) of Subjects With BMUntil disease progression, unacceptable toxicity, or up to 2 years, whichever occurred firstSubjects with BM only (Cohorts A and C). Subjects with LM (Cohort B) were excluded.Percentage of participants (%)NUMBER
PRIMARYBest ORR of Subjects With LMUntil disease progression, unacceptable toxicity, or up to 2 years, whichever occurred firstPercentage of participants (%)NUMBER
SECONDARYMedian Progression-free Survival (PFS)Until disease progression, unacceptable toxicity, or up to 2 years, whichever occurred firstWeeksMEDIAN
SECONDARYProbability of PFS at 12 Weeks and 24 Weeks--Cohort A (BM Only) and Cohort B (LM Only)24 weeks (6 months)Note: Cohort C (BM-IP) did not have a sufficient number of subjects with events to determine the PFS at 12 or 24 weeks.ProbabilityNUMBER
SECONDARYProbability of PFS at 24 Weeks--Cohort C (BM-IP Only)24 weeks (6 months)Note: Insufficient data for PFS probability at 12 weeksProbabilityNUMBER
SECONDARYProbability of OS at 12 Weeks and at 24 Weeks--Cohort A (BM Only) and Cohort B (LM Only)24 weeks (6 months)Note: Cohort C did not have a sufficient number of subjects with events to determine the probability of survival at 12 or 24 weeks.ProbabilityNUMBER
SECONDARYMedian Time to Progression (TTP)--Cohort A (BM), Cohort B (LM), Cohort C (BM-IP)Until disease progression, death, unacceptable toxicity, or up to 2 years, whichever occurred firstWeeksMEDIAN
SECONDARYProbability of TTP at 12 Weeks and 24 Weeks--Non-CNS Cohort A (BM Only) and Cohort B (LM Only)24 weeks (6 months)Note: Cohort C (BM-IP) did not have a sufficient number of subjects with events to determine the probability of TTP at 12 weeks or 24 weeks.ProbabilityNUMBER
SECONDARYProbability of TTP at 24 Weeks--CNS24 weeks (6 months)ProbabilityNUMBER
SECONDARYQuality of Life (QoL): Mean Change From Baseline in EORTC-QLQ-C30 Questionnaire ScoresUntil disease progression, unacceptable toxicity, or up to 2 years, whichever occurred firstNote: Not all subjects were available for analysis at all visits.Score on a scaleMEAN
SECONDARYQuality of Life (QoL): Mean Change From Baseline in EORTC-QLQ-BN20 Questionnaire ScoresUntil disease progression, unacceptable toxicity, or up to 2 years, whichever occurred firstNot all subjects were available for all analyses.Score 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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