Trial · NCT02639182
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | PFS was defined as the time from the date of randomization to the earliest of documented disease progression as defined by RECIST v.1.1 or death from any cause. PFS was analysed using Kaplan-Meier estimates. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (longest for non-nodal lesions, short axis for nodal lesions) of the target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of 1 or more new lesions is also considered progression. Participants were censored if there were 2 or more than 2 consecutive missing assesments immediately prior to death or progression; or no death and no postebaseline assesments; or if ininitiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed. |
| 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) | PFS was defined as the time from the date of randomization to the earliest of documented disease progression as defined by RECIST v.1.1 or death from any cause. PFS was analysed using Kaplan-Meier estimates. PD was defined as at least a 20% increase in the sum of diameters (longest for non-nodal lesions, short axis for nodal lesions) of the target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of 1 or more new lesions is also considered progression. Participants were censored if there were 2 or more than 2 consecutive missing assessments immediately prior to death or progression; or no death and no postebaseline assessments; or if initiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed. |
| 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) | ORR was defined as the percentage of participants who had a best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) with reduction in short axis to \<10mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. |
| 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) | DOR was defined as the time from the date of the first response of CR or PR (whichever was first recorded) to the first date of documented PD or death due to any cause. DOR was analysed using Kaplan-Meier estimates. CR and PR were defined in outcome measure 3 and PD was defined in outcome measures 1 and 2. Participants were censored if there were 2 or more than 2 consecutive missing assesments immediately prior to death or progression; or no death and no postebaseline assesments; or if ininitiated non protocol anticancer treatment prior to death or prior to documentation of disease progression; or alive and not progressed. |
| Secondary | Overall Survival (OS) | Date of randomization until the date of death from any cause (up to 53 months) | OS was defined as the time from the date of randomization until the date of death from any cause. OS was analysed using Kaplan-Meier estimates. Participants were censored if there was no death and no postbaseline contact or no death and at least one postbaseline follow-up. |
| 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) | DCR was defined as the percentage of patients who had a best overall response of CR, PR or at least 6 months with stable disease (SD). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) with reduction in short axis to \<10mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug. |
| Secondary | Number of Participants With Adverse Events | From first dose up to 53 months | AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, ECG data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator. AE was considered "serious" if it results in death or is life threatening results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions or results in congenital anomaly, or birth defect requires inpatient hospitalization or leads to prolongation of hospitalization or other medically important events. |
| 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) | Cmax of ADC was reported. |
| Secondary | Mean Predose Serum Concentration (Ctrough) of ADC | Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days) | Ctrough of ADC was reported. |
| 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) | Tmax of ADC was reported. |
| 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) | AUC (0 to 21) of ADC was reported. |
| 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) | t1/2 of ADC was reported. |
| 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) | Cmax of TAb was reported. |
| Secondary | Mean Predose Serum Concnetration (Ctrough) of TAb | Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days) | Ctrough of TAb was reported. |
| 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) | Tmax of TAb was reported. |
| 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) | AUC (0 to 21) of TAb was reporetd. |
| 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) | t1/2 of TAb was reported. |
| 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) | Cmax of Cys-mcMMAF was reported. |
| Secondary | Mean Predose Serum Concnetration (Ctrough) of Cys-mcMMAF | Predose on cycle 2, 3, 4, 6, 14, and 18 (each cycle is 21 days) | Ctrough of Cys-mcMMAF was reported. |
| 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) | Tmax of Cys-mcMMAF was reported. |
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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