Trial · NCT07386938
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 44
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (%) (ORR) | Up to day 126 | Objective response rate (%) (ORR) for a period of up to 18 weeks of therapy inclusive. ORR is the percentage of patients in a group achieving either a complete or partial tumor response to therapy. Complete Response (CR) is the disappearance of all target lesions confirmed by the computer tomography (CT) for at least 4 weeks; the short axis of any previously pathological lymph node (target or non-target) must be \< 10 mm. Partial Response (PR) is at least a 30% reduction in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) values |
| Secondary | Disease control rate (DCR) (%) | Up to day 126 | Disease control rate (DCR) (%) for a period of up to 18 weeks of therapy inclusive. DCR is the percentage of patients in a group achieving a complete or partial tumor response to therapy, or disease stabilization. Stable Disease (SD) is defined as neither a sufficient decrease in the sum of diameters of target lesions to qualify as a partial response, nor an increase in the sum of diameters that would be considered disease progression, compared with the smallest sum of diameters recorded during the observation period |
| Secondary | Time to tumor response to therapy (TTR) | Up to day 126 | Time to tumor response to therapy (TTR) for a period of up to 18 weeks of therapy inclusive. TTR is the time from the start of the study therapy to the first documented objective tumor response |
| Secondary | Duration of tumor response to therapy (DOR) | Up to day 126 | Duration of tumor response to therapy (DOR) for a period of up to 18 weeks of therapy inclusive. DOR is the time from the first documented objective tumor response to disease progression or death from any cause. Progression (PD) is defined as a ≥20% increase in the sum of diameters of target lesions compared with the smallest sum recorded during the observation period (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions |
| Secondary | Progression-free survival (PFS) expressed as PFS level (%) | Up to day 126 | Progression-free survival (PFS) expressed as PFS level (%) for a period of up to 18 weeks of therapy inclusive |
| Secondary | Progression-free survival (PFS) expressed as median PFS | Up to day 126 | Progression-free survival (PFS) expressed as median PFS for a period of up to 18 weeks of therapy inclusive |
| Secondary | Area under the pharmacokinetic curve "concentration-time" (AUC(0-504)) of pertuzumab | Pre-dose on Day 1 (first administration) and 1, 1.5, 2, 2.5, 4, 7, 12 hours post-dose; 24 (Day 2), 96 (Day 5), 216 (Day 10), 336 (Day 15), 504 (Day 22) hours post-dose | Area under the pharmacokinetic curve "concentration-time" of pertuzumab after the first (single dose) administration, truncated at the point before the second administration, i.e. up to 504 hours |
| Secondary | Maximum serum concentration of pertuzumab after the first administration (Cmax) | Pre-dose on Day 1 (first administration) and 1, 1.5, 2, 2.5, 4, 7, 12 hours post-dose; 24 (Day 2), 96 (Day 5), 216 (Day 10), 336 (Day 15), 504 (Day 22) hours post-dose | Maximum serum concentration of pertuzumab after the first administration (Cmax) |
| Secondary | Maximum serum concentration of pertuzumab at steady state (Cmax ss) after the 3rd administration | Pre-dose on Day 43 (+2 days, third infusion) and 1, 1.5, 2, 2.5, 4, 7, 12 hours post-dose; 24 (+72 h, Day 44 +2), 96 (+72 h, Day 47 +2), 216 (+72 h, Day 52 +2), 336 (+72 h, Day 57 +2), 504 (+72 h, Day 64 +2) hours post-dose | Maximum serum concentration of pertuzumab at steady state (Cmax ss) after the 3rd administration |
| Secondary | Minimum serum concentration of pertuzumab at steady state (Cmin ss) after the 3rd administration | Pre-dose immediately before the second, third (Day 43 +2), fourth, fifth (Day 85 +2), and sixth (Day 106 +2) infusions (≤ 30 minutes before administration) | Minimum serum concentration of pertuzumab at steady state (Cmin ss) after the 3rd administration |
| Secondary | Area under the pharmacokinetic curve "concentration-time" of pertuzumab at steady state (AUC tau ss) | Pre-dose on Day 43 (+2 days, third infusion) and 1, 1.5, 2, 2.5, 4, 7, 12 hours post-dose; 24 (+72 h, Day 44 +2), 96 (+72 h, Day 47 +2), 216 (+72 h, Day 52 +2), 336 (+72 h, Day 57 +2), 504 (+72 h, Day 64 +2) hours post-dose | Area under the pharmacokinetic curve "concentration-time" of pertuzumab at steady state (AUC tau ss) after the 3rd administration |
| Other | Objective response rate (%) (ORR) | Up to day 168 | Objective response rate (%) (ORR) for a period of up to 24 weeks of therapy inclusive |
| Other | Objective response rate (%) (ORR) (non-comparative evaluation in the RPH-051 group) | Up to day 365 | Objective response rate (%) (ORR) for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-051 group) |
| Other | Disease control (DCR) (%) | Up to day 168 | Disease control (DCR) (%) for a period of up to 24 weeks of therapy inclusive |
| Other | Disease control (DCR) (%) (non-comparative evaluation in the RPH-051 group) | Up to day 365 | Disease control (DCR) (%) within a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-051 group) |
| Other | Tumor time to response to therapy (TTR) | Up to day 168 | Tumor time to response to therapy (TTR) for a period of up to 24 weeks of therapy inclusive |
| Other | Tumor time to response to therapy (TTR) (non-comparative evaluation in the RPH-051 group) | Up to day 365 | Tumor time to response to therapy (TTR) within a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-051 group) |
| Other | Tumor duration to response to therapy (DOR) | Up to day 168 | Tumor duration to response to therapy (DOR) for a period of up to 24 weeks of therapy inclusive |
| Other | Tumor duration to response to therapy (DOR) (non-comparative evaluation in the RPH-051 group) | Up to day 365 | Tumor duration to response to therapy (DOR) within a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-051 group) |
| Other | Progression-free survival (PFS) (non-comparative evaluation in the RPH-051 group) | Up to day 168 | Progression-free survival (PFS) expressed as the rate (%) of PFS for a period of up to 24 weeks of therapy inclusive |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07386938/registered