Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT04616560
Status:
SUSPENDED
Last Update Posted:
2025-10-31
First Post:
2020-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of DS-8201a (NSC# 807708) in Adolescents, or Young Adults With Recurrent HER2+ Osteosarcoma
Status:
SUSPENDED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other - Stage 1 has met accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the effects of trastuzumab deruxtecan in treating patients with HER2 positive osteosarcoma that is newly diagnosed or has come back (recurrent). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them.
Detailed 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 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. Patients also undergo echocardiography or multigated acquisition scan (MUGA), blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 6 months.
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. Patients also undergo echocardiography or multigated acquisition scan (MUGA), blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-08428 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| UM1CA228823 | NIH | None | https://reporter.nih.gov/quic… | View |
| PEPN1924 | OTHER | Pediatric Early Phase Clinical Trial Network | View | |
| PEPN1924 | OTHER | CTEP | View |