Trial · NCT02407990
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1A: Number of Participants Experiencing Adverse Events (AEs) | Day -28 through 5 years and 2 months | Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants With Abnormal Physical Examination Values | Day 1 and Day 15 of each cycle through 30 (+/- 7) days after last dose (up to 5 years and 2 months) | Safety Analysis Set: all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants Experiencing Dose-dependent Toxicity Through Ophthalmology Findings | Day 15 of cycle 1, Day 1 of Cycle 2 and all additional cycles, and 30 (+/- 7) days after last dose (up to 5 years and 2 months) | Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants With Abnormal Electrocardiograms | Days 1 and 15 of cycle 1; Day 1 of cycle 2 and all additional cycles; Day 1 of cycle 4; 30 (+/- 7) days after last dose (up to 5 years and 2 months) | Safety Analysis Set: all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants With Abnormal Laboratory Values | Day -28 (predose), Days 1, 8, and 15 of cycle 1; Days 1 and 15 of cycle 2 and additional cycles; Days 1 and 15 of cycle 4; 30 (+/- 7) days after last dose (up to 5 years and 2 months) | Safety Analysis Set: participants who had received any dose of tislelizumab and with baseline assessment and at least one post-baseline assessment. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1A: Number Of Participants Experiencing Severe AEs | Day -28 through 5 years and 2 months | Safety Analysis Set (SAF) included all participants who had received any dose of tislelizumab. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1B: Objective Response Rate (ORR) | Day -28 through 5 years and 2 months | Efficacy Evaluable Set (EFF) included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. | percentage of participants | NUMBER |
| SECONDARY | Phase 1A: Area Under The Plasma Concentration-time Curve Within the Dosing Interval (AUC0-tau) For Tislelizumab | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | PK Analysis Set (PKS) included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | micrograms/milliliter*day | MEAN |
| SECONDARY | Phase 1A: Maximum Observed Plasma Concentration (Cmax) For Tislelizumab | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | micrograms/milliliter | MEAN |
| SECONDARY | Phase 1A: Time To Maximum Concentration (Tmax) For Tislelizumab | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | hours | MEAN |
| SECONDARY | Phase 1A: Half-life (T½) For Tislelizumab | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | PKS included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. | hours | MEAN |
| SECONDARY | Phase 1A - Part 3: Clearance (Cl) For Tislelizumab | Cycle 1 Day 1-1 hour pre-dose, End of infusion, 1, 5, 6, 24, and 72 hours post-dose; Day 15 and Cycle 2 Day 1 Pre-dose | PK Analysis Set (PKS) included participants who had received at least the first dose of tislelizumab and provided PK samples as per protocol following first dosing. per-pre-specification, data was analyzed only for Part 3 of Phase 1A. | liters/day | GEOMETRIC_MEAN |
| SECONDARY | Phase 1A/1B: Number Of Participants With Anti-drug Antibodies (ADAs) | Day 1 of Cycles 1 through 15 | Evaluable set: participants who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result. | Participants | NUMBER |
| SECONDARY | Phase 1A: ORR | Day -28 through 5 years and 2 months | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | percentage of participants | NUMBER |
| SECONDARY | Phase 1A: CR Rate | Day -28 through 5 years and 2 months | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1A: PR Rate | Day -28 through 5 years and 2 months | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1A: Stable Disease (SD) Rate | Day -28 through 5 years and 2 months | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1A: Progression-free Survival (PFS) | Day -28 through 5 years and 2 months | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date.The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | months | MEDIAN |
| SECONDARY | Phase 1A: Overall Survival (OS) | Day -28 through 5 years and 2 months | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | months | MEDIAN |
| SECONDARY | Phase 1A: Duration Of Response (DOR) | Day -28 through 5 years and 2 months | Efficacy Evaluable Set included all participants in the SAF with measurable disease at baseline per RECIST v 1.1 who had at least 1 evaluable post-baseline tumor assessment, unless discontinued due to clinical disease progression, or death within 10 weeks of the first dose date. The analysis was pre-specified to be a pooled analysis of all Part 1A cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | months | MEDIAN |
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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