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Monoclonal Antibodies
Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma
Phase 2
Waitlist Available
Led By Damon R Reed
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
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 a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them.
Eligible Conditions
- Osteosarcoma
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event-free survival of DS-8201A for HER2+ osteosarcoma
Secondary study objectives
Duration of response
Event free survival of DS-8201A for HER2+ osteosarcoma
Incidence of adverse events of DS-8201A for HER2+ osteosarcoma
+3 moreSide effects data
From 2024 Phase 2 trial • 95 Patients • NCT0498981677%
Anaemia
73%
White blood cell count decreased
61%
Neutrophil count decreased
53%
Platelet count decreased
43%
Nausea
40%
Decreased appetite
39%
Hypoalbuminaemia
32%
Aspartate aminotransferase increased
32%
Vomiting
28%
Weight decreased
26%
Hypokalaemia
25%
Asthenia
25%
Alanine aminotransferase increased
24%
Hypocalcaemia
22%
Hyponatraemia
19%
Constipation
19%
Fatigue
17%
Lymphocyte count decreased
15%
Diarrhoea
13%
Covid-19
12%
Blood alkaline phosphatase increased
12%
Gamma-glutamyltransferase increased
12%
Blood bilirubin increased
9%
Dizziness
9%
Pyrexia
9%
Hyperuricaemia
8%
Hyperglycaemia
8%
Abdominal distension
7%
Oedema peripheral
7%
Insomnia
6%
Bilirubin conjugated increased
6%
Thrombocytopenia
6%
Blood creatinine increased
6%
White blood cell count increased
6%
Hypochloraemia
6%
Abdominal pain
6%
Dyspepsia
6%
Hypoaesthesia
5%
Productive cough
5%
Pneumonia
5%
Amylase increased
5%
Back pain
5%
Mouth ulceration
5%
Hepatic function abnormal
5%
Blood lactate dehydrogenase increased
5%
Coronavirus infection
5%
Ejection fraction decreased
5%
Cough
5%
Interstitial lung disease
5%
Hypoproteinaemia
4%
Covid-19 pneumonia
3%
Gastrointestinal haemorrhage
2%
Febrile neutropenia
2%
Death
1%
Jaundice cholestatic
1%
Malnutrition
1%
Dysphagia
1%
Cerebral infarction
1%
Gastrointestinal infection
1%
Myelosuppression
1%
Arrhythmia
1%
Mental disorder
1%
Haemorrhage intracranial
1%
Haematuria
1%
Renal failure
1%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Sepsis
1%
Upper gastrointestinal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
T-DXd
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trastuzumab deruxtecan)Experimental Treatment1 Intervention
Patients receive trastuzumab deruxtecan 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab Deruxtecan
2021
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,553 Total Patients Enrolled
105 Trials studying Osteosarcoma
16,479 Patients Enrolled for Osteosarcoma
Damon R ReedPrincipal InvestigatorPediatric Early Phase Clinical Trial Network