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Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma

NCT05373901 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-10-04

Study results available
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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

Conditions

  • High-risk Neuroblastoma

Interventions

DRUG

Dinutuximab Beta

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

DRUG

13-cis-Retinoic Acid

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.

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2023-06-29
Completion
2023-06-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373901 on ClinicalTrials.gov