Trial · NCT07435324
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (%) (ORR) | At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120) | Objective response rate (%) (ORR) for a period of up to 18 weeks of therapy inclusive 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 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 |
| Secondary | Disease Control Rate (%) (DCR; CR + PR + SD) | At Visits 6 (Day 36), 12 (Day 78), and 18 (Day 120) | Disease Control Rate (DCR; CR + PR + SD), %, achieved within up to 18 weeks from the start of study treatment (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 |
| Secondary | Proportion of patients (%) with adverse drug reactions (ADRs) of any severity | Up to Day 365 | 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 365 | Proportion of patients (%) with adverse events (AEs) of any severity |
| Secondary | Proportion of patients (%) with AEs of severity grade ≥ 3 | Up to Day 365 | 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 365 | 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 365 | Proportion of patients (%) with serious adverse events (SAEs) |
| Secondary | Proportion of patients (%) with serious adverse drug reactions (SADRs) | Up to Day 365 | Proportion of patients (%) with serious adverse drug reactions (SADRs) |
| Secondary | Proportion of patients (%) who required discontinuation of treatment due to development of ADRs/SADRs | Up to Day 365 | Proportion of patients (%) who required discontinuation of treatment due to development of ADRs/SADRs |
| Secondary | Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab | Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36 | Proportion of patients (%) who developed anti-drug antibodies (ADA) to cetuximab |
| Secondary | Proportion of patients (%) who developed neutralizing antibodies (NAb) to cetuximab | Pre-dose in Period 1 on Days 1, 15, 29, 57, and 85, and 28 ± 3 days post-last infusion; pre-dose in Period 2 on Days 6, 12, 18, 24, 30, and 36 | Proportion of patients (%) who developed neutralizing antibodies (NAb) to cetuximab |
| Other | Objective response rate (%) (ORR) | Up to Week 9 (Visit 9) in Period 2 | Objective response rate (%) (ORR) for a period of up to 6 months of therapy inclusive 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 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 |
| Other | Objective response rate (%) (ORR) (non-comparative evaluation in the RPH-002 group) | At Visits 6, 12, and 18 in Period 1 (Days 36, 78, and 120) and Visits 6, 12, 18, 24, 30, and 36 in Period 2 (Weeks 6-36) | Objective response rate (%) (ORR) for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-002 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 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 |
| Other | Disease Control Rate (%) (DCR; CR + PR + SD) | Up to Week 9 (Visit 9) in Period 2 | Disease control rate (DCR; CR + PR + SD) (%) 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 | Disease Control Rate (%) (DCR; CR + PR + SD) (non-comparative evaluation in the RPH-002 group) | At Visits 6, 12, and 18 in Period 1 (Days 36, 78, and 120) and Visits 6, 12, 18, 24, 30, and 36 in Period 2 (Weeks 6-36) | Disease Control Rate (%) (DCR; CR + PR + SD) for a period of up to 1 year of therapy inclusive (non-comparative evaluation in the RPH-002 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) | Up to Week 9 (Visit 9) in Period 2 | 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) (non-comparative evaluation in the RPH-002 group) | Up to Day 365 | Progression-free survival (PFS) expressed as the rate (%) of 1-year PFS (non-comparative evaluation in the RPH-002 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-002 group) | Up to Day 365 | Overall survival (OS) expressed as median OS for a period of up to 1 year of therapy (non-comparative evaluation in the RPH-002 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.
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