Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 77
Summary
- Conditions
- Osteosarcoma
- Recurrent Osteosarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 39 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To estimate the proportion of patients with recurrent measurable osteosarcoma treated with trastuzumab deruxtecan (DS-8201a) who are event free (%EF) at 24 weeks. SECONDARY OBJECTIVES: I. To assess the safety of DS-8201a in patients with recurrent osteosarcoma. II. To describe ...
PRIMARY OBJECTIVE: I. To estimate the proportion of patients with recurrent measurable osteosarcoma treated with trastuzumab deruxtecan (DS-8201a) who are event free (%EF) at 24 weeks. SECONDARY OBJECTIVES: I. To assess the safety of DS-8201a in patients with recurrent osteosarcoma. II. To describe the pharmacokinetics of DS-8201a in patients with recurrent osteosarcoma. III. To estimate the objective response rate (ORR), event free survival (EFS), overall survival (OS) and duration of response (DOR) of patients with recurrent, measurable osteosarcoma. EXPLORATORY OBJECTIVES: I. To describe the relationship between potential biomarkers and response to DS-8201a. II. To evaluate quantitative circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and circulating tumor cells (CTCs) as a surrogate markers of response in recurrent osteosarcoma. OUTLINE: Patients receive trastuzumab deruxtecan intravenously (IV) over 30-90 minutes on day 1. Treatment repeats every 21 days for 35 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 months.
Tracking Information
- NCT #
- NCT04616560
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Damon R Reed Pediatric Early Phase Clinical Trial Network