Trial · NCT02484443
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control | 12 months after study enrollment | Patients who can be confirmed to be free of detectable disease 12 months after enrollment, without intervening disease progression, will be considered to have demonstrated 12 month disease control. All other eligible patients will be considered not to have demonstrated 12 month disease control. |
| 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 | T 1/2 alpha of the serum concentration of dinutuximab in days |
| 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 | T 1/2 beta of the serum concentration of dinutuximab in days |
| 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 | Cmax of the serum concentration dinutuximab as mg/L. |
| 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 | (AUC)0 to infinity of serum dinutuximab in mg-h/L. |
| 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 | The number of cycles where a dose-limiting toxicity was identified where dose-limiting toxicity is defined in the protocol using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Occurrence of unacceptable toxicity as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, coded as present or absent, in each cycle received by eligible patients where all prescribed therapy for the cycle is received or the patient experiences unacceptable toxicity. |
| Other | Tumor GD2 Expression | At study enrollment | Archival tumor tissue will be assessed by immunohistochemistry to provide the level of GD2 expression in tissue as an integer between 0 and 3 with 0 indicating no GD2 expression and 3 indicating strong GD2 expression. |
| Other | KIR Genotype Analyses | At enrollment | KIR mismatch will be assessed from the pre-treatment blood specimen as present or absent. |
| Other | NKp30c Genotype Analyses | At enrollment | Status of the immunosuppressive isoform of NKp30c KIR mismatch will be assessed from the pre-treatment blood specimen as present or absent. |
| Other | FcgammaR Genotype Analyses | At enrollment | FcgammaR genotype will be assessed from the pre-treatment blood specimen as H/R, R/R or H/H. |
| Other | Change in Circulating Ligand B7-H6 Levels | Cycle 1 of therapy planned to be 21 days | The change in surface expression of ligand B7-H6 in terms of counts between the blood sample taken prior to the start of protocol therapy and the end of cycle 1 will be calculated. Patients who do not receive all prescribed protocol therapy during cycle 1 will not be evaluable for this outcome measure. |
| Other | Banking of Tumor Samples (Optional) | 5 cycles of protocol therapy planned as 140 days | Individual statistical plans will be developed for future studies answering a specific question using these banked tumor specimens. |
| Other | HACA Titer | At enrollment, at the start of each cycle of therapy and within 30 days of the end of cycle 5 | HACA titer will be determined in each blood sample provided to the HACA reference laboratory. |
| Other | Circulating Tumor Deoxyribonucleic Acid Detection | 5 cycles of protocol therapy planned as 140 days | Statistical considerations for specific future studies will be provided. |
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/registered