Trial · NCT03488251
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 and 2: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 168 Days | Safety Population consisted of all participants who received at least 1 dose of any study drug (either MT-3724, or gemcitabine or oxaliplatin). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 168 Days | Safety Population. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (\>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (\>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Hours*micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (\>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Hours | MEDIAN |
| SECONDARY | Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range | Up to 168 Days | Safety Population. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Number of Participants With Anti-drug Antibody Titer | Up to 168 Days | Immunogenicity population: All participants who received at least one dose of MT-3724 and have at least one post-Baseline immunogenicity assessment. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies | Up to 168 Days | Immunogenicity population. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Objective Response Rate | Up to 168 Days | Efficacy Population: All participants who received at least 1 dose of any study drug and have the Baseline tumor assessment as well as at least one post-Baseline tumor assessment. Only those participants with data available at the specified time points were analyzed. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Disease Control Rate | Up to 168 Days | Efficacy Population. Only those participants with data available at the specified time points were analyzed. Data could not be calculated for Part 1: Cohort 1 as no participants had a confirmed CR or PR. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Duration of Response | Up to 168 Days | Efficacy Population. Only those participants with data available at the specified time points were analyzed. Data could not be calculated for Part 1: Cohort 1 as no participants had a confirmed CR or PR. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Months | MEDIAN |
| SECONDARY | Part 1 and 2: Progression-free Survival | Up to 168 Days | Efficacy Population. Only those participants with data available at the specified time points were analyzed. Data could not be calculated for Part 1: Cohort 1 as no participants had a confirmed CR or PR. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Months | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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
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GET https://conductscience.org/api/trials/v1/NCT03488251/outcomes