CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 8 enrolled
Drug / intervention
Dinutuximab Beta +1 moredrug
Likely dose
Dinutuximab Beta 10 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05373901
NCT05373901Phase 1Completed
CompareCT.gov

An Open-Label, Multi-Center, Single-Arm, Phase 1 Study Evaluating the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-Risk Neuroblastoma

BeiGene·interventional·Posted May 13, 2022·Updated Oct 4, 2024

In Brief

A Phase 1 clinical trial evaluating Dinutuximab Beta and 13-cis-Retinoic Acid for High-risk Neuroblastoma. Completed, enrolled 8 participants across 3 sites.

Detailed Summary

This was an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study was for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese participants with high-risk neuroblastoma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh-risk Neuroblastoma
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedMay 13, 2022
Enrollment StartJun 7, 2022
Primary CompletionJun 29, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.1 years ago

Interventions

Dinutuximab Betadrug

Dinutuximab beta was administered intravenously at a dosage of 10 milligrams/ meters squared (mg/m2) per day for 10 consecutive days

13-cis-Retinoic Aciddrug

13-cis-Retinoic Acid was administered orally at a daily total dose of 160 mg/m2, divided into approximately two equal doses given twice daily for 14 days following the conclusion of dinutuximab beta infusion.