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Trial · NCT03088813

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)Part 1: Irinotecan Liposome Injection 85 mg/m^2Any TEAE5Participants
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)Part 1: Irinotecan Liposome Injection 70 mg/m^2Any TEAE25Participants
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)Part 1: Irinotecan Liposome Injection 85 mg/m^2Serious TEAEs4Participants
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)Part 1: Irinotecan Liposome Injection 70 mg/m^2Serious TEAEs9Participants
Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)Part 1: Irinotecan Liposome Injection 85 mg/m^24Participants
Part 1: Number of Participants With Dose-Limiting Toxicities (DLT)Part 1: Irinotecan Liposome Injection 70 mg/m^22Participants
Part 2: Overall Survival (OS)Part 2: Irinotecan Liposome Injection 70 mg/m^27.9295% Confidence Interval 6.87 to 9.23months
Part 2: Overall Survival (OS)Part 2: Topotecan 1.5 mg/m^28.3195% Confidence Interval 7.33 to 9.13months
Part 1: Objective Response Rate (ORR)Part 1: Irinotecan Liposome Injection 85 mg/m^24095% Confidence Interval 5.27 to 85.34percentage of participants
Part 1: Objective Response Rate (ORR)Part 1: Irinotecan Liposome Injection 70 mg/m^24495% Confidence Interval 24.40 to 65.07percentage of participants
Part 1: Progression-Free Survival (PFS)Part 1: Irinotecan Liposome Injection 85 mg/m^24.1995% Confidence Interval 1.58 to NAmonths
Part 1: Progression-Free Survival (PFS)Part 1: Irinotecan Liposome Injection 70 mg/m^23.9895% Confidence Interval 2.69 to 4.24months
Part 1: OSPart 1: Irinotecan Liposome Injection 85 mg/m^210.8495% Confidence Interval 0.99 to NAmonths
Part 1: OSPart 1: Irinotecan Liposome Injection 70 mg/m^28.0895% Confidence Interval 5.16 to 9.82months
Part 2: PFSPart 2: Irinotecan Liposome Injection 70 mg/m^24.0195% Confidence Interval 2.96 to 4.17months
Part 2: PFSPart 2: Topotecan 1.5 mg/m^23.2595% Confidence Interval 2.79 to 4.14months
Part 2: ORRPart 2: Irinotecan Liposome Injection 70 mg/m^244.195% Confidence Interval 37.57 to 50.79percentage of participants
Part 2: ORRPart 2: Topotecan 1.5 mg/m^221.695% Confidence Interval 16.44 to 27.41percentage of participants
Part 2: Median Duration of Response (DoR)Part 2: Irinotecan Liposome Injection 70 mg/m^24.1495% Confidence Interval 3.06 to 4.34months
Part 2: Median Duration of Response (DoR)Part 2: Topotecan 1.5 mg/m2 IV4.1795% Confidence Interval 2.86 to 4.76months

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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