Trial · NCT02639182
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Investigator Radiologic Review | From date of randomization to the earliest of either documented disease progression or death from any cause (up to 53 months) | FAS Population | Months | MEDIAN |
| SECONDARY | PFS Per RECIST v1.1 as Assessed by Blinded Central Radiology Assessment | From date of randomization to the earliest of either documented disease progression or death from any cause (up to 40 months) | FAS Population | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Based on the Investigator's Radiographic Assessment | From date of randomization until data cutoff date of 21 August 2019 (up to 40 months) | FAS Population | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Based on the Investigator's Radiographic Assessment | From date of first objective response until data cutoff date of 21 August 2019 (up to 40 months) | FAS Population | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Date of randomization until the date of death from any cause (up to 53 months) | FAS Population | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Based on the Investigator's Radiographic Assessment | Date of randomization until data cutoff date of 21 August 2019 (up to 40 months) | FAS Population | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | From first dose up to 53 months | Safety Population: All randomized participants who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) of Antibody Drug Conjugate (ADC) | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | Pharmacokinetic Population (PKAS): (included all participants who were randomized to receive AGS-16C3F and had sufficient serum concentration data to facilitate derivation of at least 1 pharmacokinetic parameter, and for whom the time of dosing on the day of sampling was known) with available data at specified time point. | Microgram per Milliliter (μg/mL) | MEAN |
| SECONDARY | Mean Predose Serum Concentration (Ctrough) of ADC | Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days) | PKAS Population. Here, number of participants analyzed signifies participants who had quantifiable data. | Nanogram per Milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Maximum Observed Serum Concentration (Tmax) of ADC | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | Days | MEDIAN |
| SECONDARY | Area Under the Concentration Versus Time Curve From Time Zero to 21days (AUC0 to 21) of ADC | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | Day*Microgram per Milliliter (day*μg/mL) | MEAN |
| SECONDARY | Terminal Elimination Half-life (t1/2) of ADC | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | Days | MEDIAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of Total Antibody (TAb) | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | μg/mL | MEAN |
| SECONDARY | Mean Predose Serum Concnetration (Ctrough) of TAb | Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days) | PKAS Population. Here, number of participants analyzed signifies participants who had quantifiable data. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Observed Serum Concentration (Tmax) of Tab | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | Days | MEDIAN |
| SECONDARY | Area Under the Concentration Versus Time Curve From Time Zero to 21days (AUC0 to 21) of TAb | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | day*μg/mL | MEAN |
| SECONDARY | Terminal Elimination Half-life (t1/2) of Tab | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | Days | MEDIAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of Cysteine Adduct of Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | ng/mL | MEAN |
| SECONDARY | Mean Predose Serum Concnetration (Ctrough) of Cys-mcMMAF | Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days) | PKAS Population. Here, number of participants analyzed signifies participants who had quantifiable data. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Observed Serum Concentration (Tmax) of Cys-mcMMAF | Predose, end of infusion, 4, 24, 72, 336 hours postdose of cycle 1 and cycle 4 (each cycle is 21 days) | PKAS Population with available data at specified time point. | Days | 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02639182/outcomes