Trial · NCT03349333
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate(ORR) by International Working Group Criteria | 2 years | The primary analysis was based on the independent review data using the safety population, safety population is 71 for this study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response (TTR) | 2 years | The secondary analyses was performed using the safety population and repeated using the per-protocol population. | months | MEAN |
| SECONDARY | Progression-Free Survival (PFS) | 2 years | The secondary analyses was performed using the safety population and repeated using the per-protocol population. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 4 years | The secondary analyses was performed using the safety population and repeated using the per-protocol population. | months | MEDIAN |
| SECONDARY | Duration of Responses | 4 years | The secondary analyses was performed using the safety population and repeated using the per-protocol population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events | 4 years | safety population | percentage of participants | NUMBER |
| SECONDARY | Area Under the Curve [AUC] for R-pralatrexate | Cycle 1 day1，Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection) | Based on PK population | h*ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve [AUC] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | h*ng/ml | GEOMETRIC_MEAN |
| SECONDARY | Steady State Volume of Distribution [Vdss] for R-pralatrexate | Cycle 1 day 1, Cycle 1 week6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection) | PK population | L | MEAN |
| SECONDARY | Steady State Volume of Distribution [Vdss] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | L | MEAN |
| SECONDARY | Steady State Clearance [CLss] for R-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | L/h | MEAN |
| SECONDARY | Steady State Clearance [CLss] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | L/h | MEAN |
| SECONDARY | Maximum Observed Plasma Concentration [Cmax] for R-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration [Cmax] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time of Cmax Observation [Tmax] for R-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | h | MEDIAN |
| SECONDARY | Time of Cmax Observation [Tmax] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | h | MEDIAN |
| SECONDARY | Terminal Phase Half-life [t1/2Z] for R-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | h | MEAN |
| SECONDARY | Terminal Phase Half-life [t1/2Z] for S-pralatrexate | Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection） | PK population | h | 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/NCT03349333/outcomes