Trial · NCT03088813
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) | The TEAEs were reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration, approximately 680 days | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Dose-Limiting Toxicities (DLT) | From the start of the first study treatment administration (Day 1) up to 14 days after the second dose of study treatment administration, a maximum of 42 days | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2: Overall Survival (OS) | From date of randomization (within 7 days before start of study treatment) until death. Assessed up to Part 2 primary analysis DCO date of 08 February 2022 (approximately 900 days) | Part 2: The ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Part 1: Objective Response Rate (ORR) | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 1177 days | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | percentage of participants | NUMBER |
| SECONDARY | Part 1: Progression-Free Survival (PFS) | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 1177 days | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | months | MEDIAN |
| SECONDARY | Part 1: OS | From Baseline (Day 1) until death. Assessed up to Part 1 DCO date of 11 August 2021 (approximately 1177 days) | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | months | MEDIAN |
| SECONDARY | Part 2: PFS | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days | Part 2: The ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Part 2: ORR | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days | Part 2: The ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Part 2: Median Duration of Response (DoR) | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days | Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed. | months | MEDIAN |
| SECONDARY | Part 2: Median Time to Objective Response (OR) | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days | Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed. | months | MEDIAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)/Lung Cancer Supplement (LC13) Dyspnea Scale at Week 12 | Baseline (Day 1) and Week 12 | Part 2: The ITT population included all randomized participants. Only participants analyzed at Week 12 are reported. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in EORTC QLQ-LC13 Cough Scale at Week 12 | Baseline (Day 1) and Week 12 | Part 2: The ITT population included all randomized participants. Only participants analyzed at Week 12 are reported. | scores on a scale | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03088813/outcomes