Trial · NCT03363373
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
NCT03363373, Phase 2, Active not recruiting, Y-mAbs Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow. Trials, record NCT03363373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03363373
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
- NCT number
- NCT03363373
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 122 participants, estimated
- Lead sponsor
- Y-mAbs Therapeutics
- Conditions
- Neuroblastoma
- Interventions
- GM-CSF + Naxitamab
- First posted
- 2017-12-06
- Last updated
- 2026-07-30
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03363373
GET https://conductscience.org/api/trials/v1/NCT03363373/registered?page=2