Trial · NCT04394624
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Hematology | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only those participants with data collected are reported. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Metabolism | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Electrolytes | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Renal Function | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Liver Function | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Electrocardiogram (ECG) | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Potentially Clinically Significant Abnormalities: Urinalysis | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Doublet Cohort: Duration of Response (DOR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. Only responders (participants with CR or PR with confirmation of response by investigator) were analyzed in this outcome measure. | months | MEDIAN |
| SECONDARY | Doublet Cohort: Progression-Free Survival (PFS) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | months | MEDIAN |
| SECONDARY | Doublet Cohort: Disease Control Rate (DCR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | percentage of participants | NUMBER |
| SECONDARY | Triplet Cohort: Objective Response Rate | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | No participants were enrolled in the triplet cohort due to the early termination of the study. | ||
| SECONDARY | Doublet Cohort: Maximum Observed Concentration (Cmax) of Tusamitamab Ravtansine | Day 1 of Cycles 1 and 4 | The Pharmacokinetic (PK) population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only participants analyzed and data collected at specific timepoints are reported. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | Doublet Cohort: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 14 Days (AUC0-14d) of Tusamitamab Ravtansine | Day 1 of Cycles 1 and 4 | The PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only participants analyzed and data collected at specific timepoints are reported. | day*mcg/mL | MEAN |
| SECONDARY | Doublet Cohort: Concentration Observed Before Treatment Administration During Repeated Dosing (Ctrough) of Ramucirumab | Cycle 2 Day 1 | The PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only participants analyzed and data collected at Cycle 2 Day 1 are reported. | nanogram/mL | MEAN |
| SECONDARY | Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine | From first dose of study drug (Day 1) up to Day 30 post last dose of study drug, approximately 134 weeks | The ATA population included all participants from the all-treated population with at least 1 post-baseline ATA result (negative, positive, or inconclusive). No participants were enrolled in the triplet cohort due to the early termination of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Doublet Cohort - Part 1: Number of Participants With Study Drug-Related Dose-Limiting Toxicity (DLT) | From Cycle 1 Day 1 up to Cycle 2 Day 14, approximately 28 days | DLT-evaluable (Part 1) population included all enrolled participants who received 2 cycles with at least 80% of the intended dose for both tusamitamab ravtansine and ramucirumab at each of the 2 first infusions unless they discontinued the study intervention before the end of Cycle 2 due to a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Doublet Cohort - Part 2: Objective Response Rate (ORR) | Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 130 weeks | All-treated population included all enrolled participants exposed to the study treatment, regardless of the amount of treatment administered. | percentage of participants | NUMBER |
| PRIMARY | Triplet Cohort: Number of Participants With Study Drug-Related Dose-Limiting Toxicity | From Cycle 1 Day 1 up to Cycle 1 Day 21 | No participants were enrolled in the triplet cohort due to the early termination of the study. |
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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