Trial · NCT07543744
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 36 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Other | Elimination rate constant of panitumumab after the first administration (Kel) | Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose | Elimination rate constant of panitumumab after the first administration (Kel) |
| Other | Area under the pharmacokinetic curve "concentration-time" of panitumumab to infinity at steady state (AUC(0-∞) ss) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Area under the pharmacokinetic curve "concentration-time" of panitumumab to infinity at steady state (AUC(0-∞) ss) |
| Other | Time to reach the maximum concentration of panitumumab at steady state (Tmax ss) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Time to reach the maximum concentration of panitumumab at steady state (after the third administration) (Tmax ss) |
| Other | Elimination half-life of panitumumab at steady state (T1/2 ss) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Elimination half-life of panitumumab at steady state (after the third administration) (T1/2 ss) |
| Other | Volume of distribution of panitumumab at steady state (Vd ss) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Volume of distribution of panitumumab at steady state (after the third administration) (Vd, ss) |
| Other | Elimination rate constant of panitumumab at steady state (Kel ss) | Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose | Elimination rate constant of panitumumab at steady state (after the third administration) (Kel ss) |
| Other | Objective response rate (%) (ORR) for a period of up to 6 months of therapy inclusive | once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main period | The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks compared with the baseline sum at screening |
| Other | Disease control rate (DCR) (%) | once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main period | Disease control rate (DCR) (%) for a period of up to 6 months of therapy inclusive The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study |
| Other | Progression-free survival (PFS) expressed as the rate (%) of 6-month PFS | Up to day 182 | Progression-free survival (PFS) expressed as the rate (%) of 6-month PFS PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause |
| Other | Progression-free survival (PFS) expressed as the median PFS for a period of up to 6 months of therapy inclusive | Up to day 182 | Progression-free survival (PFS) expressed as the median PFS for a period of up to 6 months of therapy inclusive PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause |
| Other | Objective response rate (%) (ORR) (non-comparative evaluation in the RPH-030 group) | once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main Period; on days 225 (week 33), 281 (week 41), 337 (week 49) of the Period of continued therapy | Objective response rate (%) (ORR) for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-030 group) The objective response rate (ORR) is defined as the percentage of patients in each treatment group who achieve a complete or partial tumor response to therapy according to RECIST 1.1 criteria: * Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \< 10 mm * Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks compared with the baseline sum at screening |
| Other | Disease control rate (DCR) (%) (non-comparative evaluation in the RPH-030 group) | once at screening, on days 43 (week 7), 85 (week 13), 127 (week 19), 182 (week 26) of the Main Period; on days 225 (week 33), 281 (week 41), 337 (week 49) of the Period of continued therapy | Disease control (DCR) (%) within a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-030 group) The disease control rate is defined as the percentage of patients in a given treatment group who achieve a complete response, partial response, or stable disease during therapy, in accordance with RECIST 1.1 criteria: * Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be \<10 mm * Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) measurements * Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease compared with the smallest sum recorded during the study |
| Other | Progression-free survival (PFS) (non-comparative evaluation in the RPH-030 group) | Up to day 351 | Progression-free survival (PFS) expressed as the rate (%) of 1-year PFS (non-comparative evaluation in the RPH-030 group) PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause |
| Other | Progression-free survival (PFS) (non-comparative evaluation in the RPH-030 group) | Up to day 351 | Progression-free survival (PFS) expressed as the median PFS for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-030 group) PFS is defined as the time from randomization to disease progression according to RECIST 1.1 (an increase of at least 20% in the sum of diameters of target lesions compared with the smallest sum recorded during the study (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions), clinical progression, or death from any cause |
| Other | Overall survival (OS) (non-comparative evaluation in the RPH-030 group) | Up to day 351 | Overall survival (OS) expressed as the rate (%) of 1-year OS (non-comparative evaluation in the RPH-030 group) |
| Other | Overall survival (OS) (non-comparative evaluation in the RPH-030 group) | Up to day 351 | Overall survival (OS) expressed as the median OS for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-030 group) |
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
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GET https://conductscience.org/api/trials/v1/NCT07543744/registered?page=2