Vactosertib for Recurrent, Refractory, or Progressive Osteosarcoma
This study is testing a drug called vactosertib in adolescents and adults with osteosarcoma (a type of bone cancer) that has returned, is resistant to treatment, or has gotten worse. Vactosertib is given by mouth twice a day, five days on and two days off, in four-week cycles. It works by blocking a protein called TGF-beta type 1 receptor, which can help stop cancer growth. Researchers want to see how safe vactosertib is and if it can shrink tumors. The study plans to enroll 48 participants aged 12 and older. The main goal is to find the safest and most effective dose of vactosertib.
- Study design
- This is a Phase I/II, open-label (meaning you and your doctors will know what treatment you are receiving), single-arm study, meaning all participants will receive vactosertib. It aims to enroll 48 participants.
- What's involved
- You would take vactosertib twice a day, five days on and two days off, in four-week cycles. Your safety will be monitored through adverse event assessments and laboratory tests throughout the study, which is expected to last about one year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be assessed through adverse events and laboratory abnormalities until the end of the study, which is an average of one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma
At a glance
Conditions
Where it's being run
3 sites across 2 statesWho to contact
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What this trial measures
- Dose finding associated with the overall nature and severity of AEs associated with treatment.Assessment of adverse events and laboratory abnormalities. through study completion, an average of 1 year
Maximum tolerated dose (MTD) and recommended dose (RD)