Actively Recruiting
Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma
Led by MedPacto, Inc. · Updated on 2025-04-10
48
Participants Needed
3
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
MP-VAC-209 is a Phase I/II, open label, single arm, multi-center study to assess safety, tolerability, and antitumor activity of vactosertib as a single agent in adolescents and adults with recurrent, refractory, or progressive osteosarcoma. Vactosertib is given orally, twice a day, to people 12 years of age and older who meet the criteria for study enrollment.
CONDITIONS
Official Title
Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent or assent
- Age 12 years or older at screening
- Histologic confirmation of osteosarcoma
- Measurable disease per RECIST 1.1 criteria
- Disease progressed, relapsed, or refractory to standard therapy
- Recovery to Grade 1 or less from prior chemotherapy and immunotherapy side effects (except alopecia, anorexia, bone and tumor pain)
- Adequate recovery of blood counts after prior myelosuppressive chemotherapy
- Adequate renal function
- ECOG performance status 0-2
- Lansky performance status 50-100% if under 16 years old or Karnofsky 50-100% if 16 years or older
- Normal organ and marrow function including ANC ≥ 750/mcL, platelets ≥ 75,000/mcL, hemoglobin ≥ 8.0 g/dL
- Liver function within specified limits
- Cardiac function with ejection fraction ≥ 50%
- Willingness and ability to sign consent or assent forms
- Relapsed osteosarcoma with progressive disease within 3 months of trial entry
You will not qualify if you...
- Moderate or severe cardiovascular disease or uncontrolled illnesses
- Serious cardiac abnormalities or arrhythmias
- Elevated brain natriuretic peptide or troponin at screening
- Risk factors for ascending aortic aneurysm or history of heart/aorta surgery
- Significant gastrointestinal bleeding within 4 weeks prior to screening
- Known allergy to study drug components
- Prior treatment targeting TGF-beta signaling pathway
- Use of certain drugs affecting cytochrome P-450 or other specified enzymes/transporters
- Unable to swallow tablets
- History or suspicion of drug abuse
- Positive pregnancy test or inability to use effective contraception during the study
- Investigator judgment deeming subject unsuitable for participation
- Recent use of other investigational products within specified washout periods
- Conditions or treatments that could interfere with study results or participation
- HIV positive or on antiretroviral therapy
- Active or acute infections
- Non-metastatic osteosarcoma with available standard therapy
- Chronic use of corticosteroids or immunosuppressive agents exceeding defined dosage or duration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
UH Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
2
National Cancer Center
Gyeonggi-do, South Korea
Actively Recruiting
3
Korea Institute of Radiological & Medical Sciences
Seoul, South Korea
Actively Recruiting
Research Team
K
Kristen VanHeyst, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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