Trial · NCT03363373
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response rate during Naxitamab treatment | 101 weeks | Overall objective response rate (ORR) during the Naxitamab treatment period that will be centrally assessed according to the International Neuroblastoma Response Criteria (INRC) modified with 123I-MIBG criteria and following the use of 18F FDG-PET for MIBG non-avid lesions. |
| Secondary | Incidence of adverse events and serious adverse events | 101 weeks | Safety will be evaluated by the incidence of adverse events (AE) and serious adverse events (SAEs) graded according to CTCAE, version 4.0. |
| Secondary | Duration of Response (DoR) | 101 weeks | Length of time from patient response to disease progression. |
| Secondary | Complete Response Rate | 101 weeks | The complete response (CR) rate is defined as the fraction of patients experiencing a CR according to International Neuroblastoma Response Criteria (INRC) criteria during the treatment period. |
| Secondary | Assessment of the maximum serum concentration (cmax) of naxitamab | Pre-naxitamab dose - 552 hours | Calculation of maximum serum concentration of naxitamab will be calculated and summarized with descriptive statistics. |
| Secondary | Assessment of the minimum serum concentration (cmin) of naxitamab | Pre-naxitamab dose - 552 hours | Calculation of minimum serum concentration of naxitamab will be calculated and summarized with descriptive statistics. |
| Secondary | Assessment of the clearance of naxitamab | Pre-naxitamab dose - 552 hours | Calculation of clearance of naxitamab will be calculated and summarized with descriptive statistics. |
| Secondary | Assessment of the volume of distribution of naxitamab | Pre-naxitamab dose - 552 hours | Calculation of the volume of distribution of naxitamab will be calculated and summarized with descriptive statistics. |
| Secondary | Assessment of the Area under the Curve (AUC) of naxitamab | Pre-naxitamab dose - 552 hours | Calculation of the AUC of naxitamab will be calculated and summarized with descriptive statistics. |
| Secondary | Assessment of the terminal half-life (t½) of naxitamab | Pre-naxitamab dose - 552 hours | Calculation of the t½ of naxitamab will be calculated and summarized with descriptive statistics. |
| Secondary | Assessment of anti-drug antibody (ADA) formation | Pre-naxitamab dose - 552 hours | ADA formation will be investigated following a multi-tiered approach: A screening confirmation-titration analysis plus a ligand binding assay to examine a potential neutralizing effect of anti-naxitamab antibodies. |
| Secondary | Intravenous (IV) opioid use (cycle 1) | 6 hours | IV opioid use during cycle 1 defined as total dosage of IV morphine (or equivalent opioid) administered 2 hours before infusion until 4 hours after end of infusion of naxitamab |
| Secondary | Intravenous (IV) opioid use (all cycles) | 101 weeks | IV opioid use for each cycle during the trial defined as total dosage of IV morphine (or equivalent opioid) administered 2 hours before infusion until 4 hours after end of infusion of naxitamab |
| Secondary | Hospitalization days (cycle 1) | 4 weeks | Number of hospitalization days related to naxitamab during cycle 1, defined as number of overnight stays. Hospitalizations required solely for protocol-specified assessments (e.g., PK sampling) or non-medical circumstances are excluded |
| Secondary | Safety of patients with positive human anti-drug antibody (ADA) | 101 weeks | In patients with positive ADA at trial inclusion, safety will be evaluated by the incidence of AEs and SAEs graded according to CTCAE, version 4.0 |
| Secondary | Number of infusions done in an outpatient setting | 101 weeks | Number of infusions done in an outpatient setting |
| Secondary | Percentage of infusions done in an outpatient setting | 101 weeks | Percentage of infusions done in an outpatient setting |
| Secondary | Incidence of adverse events and serious adverse events in ADA positive patients | 101 weeks | Safety will be evaluated by the incidence of adverse events (AE) and serious adverse events (SAEs) graded according to CTCAE, version 4.0 in ADA positive patients. |
| Secondary | Progression Free Survival (PFS) | 5 years | PFS, defined as the time from the first 1st infusion of naxitamab until progressive disease or death, whichever comes first |
| Secondary | Overall Survival | 5 years | The interval from the date of first dose of Naxitamab until the date of death due to any cause. |
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.
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