Trial · NCT07334301
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival time | From date of randomization until the date of first documented failure event (progression or death), assessed up to 60 months. | • Progression-Free Survival time (as per International Neuroblastoma Response Criteria (PD Progressive disease, SD Stable disease, MR Minor response, PR Partial response, CR Complete response) INRC 2017) - for Tier 1 (randomised comparison) |
| Primary | Occurrence of dose-limiting toxicities to definition of a safe and tolerable combination regimen | From date of randomization until the date of first documented failure event (progression or death), assessed up to 60 months. | Tier 2 (dose expansion-confirmation cohorts): Definition of a safe and tolerable (i.e. \</= 3 dose-limiting toxicities) combination regimen |
| Secondary | Best objective response | At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days) | Best objective response (complete and partial response) per the INRC 2017 during trial treatment (12 cycles) |
| Secondary | Clinical benefit | At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days) | Clinical benefit (complete, partial and minor response and stable disease) per the INRC 2017 (International Neuroblastoma Response Criteria (PD Progressive disease, SD Stable disease, MR Minor response, PR Partial response, CR Complete response)) |
| Secondary | Time response to progression | From date of response (Complete Response, Partial Response or Minor Response as per INRC) until the date of first documented failure event (progression or death), assessed up to 60 months. | Time between Response to Progression (i.e. Duration of Response) for patients who respond |
| Secondary | Overall Survival time | From date of trial entry until the date of first documented failure event (progression or death), assessed up to 60 months. | Overall Survival time |
| Secondary | Quality of life of patients measured by Peds-QL questionnaires | At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days) | Quality of life of patients measured by Pediatric Quality of Life Inventory (Peds-QL) questionnaires. 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher PedsQL 3.0 scores indicate better Health Related Quality of Life (HRQOL). |
| Secondary | Incidence and Severity of AEs | From date of trial entry until the date of last follow up, assessed up to 60 months. | Incidence and Severity of AEs |
| Other | Quality of life of caregivers measured by Peds-QL questionnaires | At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days) | Quality of life of caregivers measured by Pediatric Quality of Life Inventory (Peds-QL) questionnaires. 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher PedsQL 3.0 scores indicate better Health Related Quality of Life (HRQOL) |
| Other | Correlation between objective response using INRC 2017 and PFS/OS | At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days) | Correlation between objective response using INRC 2017 and PFS/OS |
| Other | Changes in circulating biomarkers and tumour molecular profiles in tumour and blood | At the end of the last treatment cycle, up to 12 cycles (each cycle is 21 days) | Changes molecular and genetic profile of tumour and blood as measured by genetic analysis at baseline and throughout the study. |
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
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GET https://conductscience.org/api/trials/v1/NCT07334301/registered