Trial · NCT02484443
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control | 12 months after study enrollment | All eligible patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | T 1/2 Alpha of the Serum Concentration of Dinutuximab | Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1 | Analysis population includes only patients for whom blood samples were submitted for pharmacokinetic analysis. | days | MEDIAN |
| SECONDARY | T 1/2 Beta of the Serum Concentration of Dinutuximab | Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1 | Analysis population includes only patients for whom blood samples were submitted for pharmacokinetic analysis. | days | MEDIAN |
| SECONDARY | Maximum of Concentration (Cmax) of the Serum Concentration Dinutuximab | Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1 | Analysis population includes only patients for whom blood samples were submitted for pharmacokinetic analysis. | mg/L | MEDIAN |
| SECONDARY | Area Under the Curve (AUC)0 to Infinity of Serum Dinutuximab | Cycle 1 Day 4 and Day 7: pre-infusion, hour 4-6, end of infusion, 4-8 hours post infusion. Once between days 11-17. Cycle 2 Day 0 or 1 | Analysis population includes only patients for whom blood samples were submitted for pharmacokinetic analysis. | mg-h/L | MEDIAN |
| SECONDARY | Number of Cycles Where an Unacceptable Toxicity as Defined in the Protocol Using The National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 Was Observed | 5 cycles of protocol therapy planned as 140 days | 39 patients were treated on protocol therapy. One hundred thirty-six cycles were reported for the analysis of dose limiting toxicity | cycles | NUMBER |
| OTHER_PRE_SPECIFIED | Tumor GD2 Expression | At study enrollment | |||
| OTHER_PRE_SPECIFIED | KIR Genotype Analyses | At enrollment | |||
| OTHER_PRE_SPECIFIED | NKp30c Genotype Analyses | At enrollment | |||
| OTHER_PRE_SPECIFIED | FcgammaR Genotype Analyses | At enrollment | |||
| OTHER_PRE_SPECIFIED | Change in Circulating Ligand B7-H6 Levels | Cycle 1 of therapy planned to be 21 days | |||
| OTHER_PRE_SPECIFIED | Banking of Tumor Samples (Optional) | 5 cycles of protocol therapy planned as 140 days | |||
| OTHER_PRE_SPECIFIED | HACA Titer | At enrollment, at the start of each cycle of therapy and within 30 days of the end of cycle 5 | |||
| OTHER_PRE_SPECIFIED | Circulating Tumor Deoxyribonucleic Acid Detection | 5 cycles of protocol therapy planned as 140 days |
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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GET https://conductscience.org/api/trials/v1/NCT02484443/outcomes