Trial · NCT07543744
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area under the pharmacokinetic curve "concentration-time" (AUC(0-336)) of panitumumab | 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 | Area under the pharmacokinetic curve "concentration-time" of panitumumab after the first (single dose) administration, truncated at the point before the second administration, i.e. up to 336 hours |
| Primary | Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (AUC tau 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 at steady state (after the third administration) (AUC tau ss) |
| Secondary | Maximum serum concentration of panitumumab after the first administration (Cmax) | 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 | Maximum serum concentration of panitumumab after the first administration (Cmax) |
| Secondary | Maximum serum concentration of panitumumab at steady state (Cmax 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 | Maximum serum concentration of panitumumab at steady state (after the third administration) (Cmax ss) |
| Secondary | Minimum serum concentration of panitumumab at steady state (Cmin 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 | Minimum serum concentration of panitumumab at steady state (in three administrations) (Cmin ss) |
| Secondary | Residual concentration of panitumumab at steady state (Ctrough) | 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 | Residual concentration of panitumumab at steady state (before the third administration) (Ctrough) |
| Secondary | Proportion of patients (%) with adverse drug reactions (ADRs) of any severity | Up to day 729 | Proportion of patients (%) with adverse drug reactions (ADRs) of any severity |
| Secondary | Proportion of patients (%) with adverse events (AEs) of any severity | Up to day 729 | Proportion of patients (%) with adverse events (AEs) of any severity |
| Secondary | Proportion of patients (%) with AEs of severity grade ≥ 3 | Up to day 729 | Proportion of patients (%) with AEs of severity grade ≥ 3 according to CTCAE 5.0 |
| Secondary | Proportion of patients (%) with ADRs of severity grade ≥ 3 | Up to day 729 | Proportion of patients (%) with ADRs of severity grade ≥ 3 according to CTCAE 5.0 |
| Secondary | Proportion of patients (%) with serious adverse events (SAEs) | Up to day 729 | Proportion of patients (%) with serious adverse events (SAEs) |
| Secondary | Proportion of patients (%) with serious adverse drug reactions (SADRs) | Up to day 729 | Proportion of patients (%) with serious adverse drug reactions (SADRs) |
| Secondary | Proportion of patients (%) who required discontinuation of treatment due to development of ADRs | Up to day 729 | Proportion of patients (%) who required discontinuation of treatment due to development of ADRs |
| Secondary | Proportion of patients (%) who developed anti-drug antibodies (ADA) to panitumumab | Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose | Proportion of patients (%) who developed anti-drug antibodies (ADA) to panitumumab |
| Secondary | Proportion of patients (%) who developed neutralizing antibodies (NAb) to panitumumab | Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose | Proportion of patients (%) who developed neutralizing antibodies (NAb) to panitumumab |
| Secondary | Proportion of patients (%) developing dermatologic toxicity | Up to day 729 | Proportion of patients (%) developing dermatologic toxicity |
| Other | Area under the pharmacokinetic curve "concentration-time" (AUC(0-∞)) of panitumumab | 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 | Area under the pharmacokinetic curve "concentration-time" of panitumumab after the first administration to infinity (AUC(0-∞)) |
| Other | Time to reach the maximum concentration of panitumumab in the blood serum after the first administration (Tmax) | 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 | Time to reach the maximum concentration of panitumumab in the blood serum after the first administration (Tmax) |
| Other | Elimination half-life of panitumumab after the first administration (T1/2) | 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 half-life of panitumumab after the first administration (T1/2) |
| Other | Volume of distribution of panitumumab after the first administration (Vd) | 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 | Volume of distribution of panitumumab after the first administration (Vd) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07543744/registered