OncoMatch/Clinical Trials/NCT05588648
Study to Assess Safety and Efficacy of Vactosertib in Adolescents and Adults With Recurrent, Refractory or Progressive Osteosarcoma
Is NCT05588648 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Vactosertib for osteosarcoma.
Treatment: Vactosertib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Osteosarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: conventional therapy
have progressed, relapsed or become refractory to conventional therapy
Cannot have received: TGF-β pathway inhibitor
Subjects who have received prior treatment targeting the signaling pathway of TGF-β
Cannot have received: other investigational products
Exception: washout period of 28 days or 5 half-lives
Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-times the half-life of the investigational product
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) ≥ 750/mcL; Platelet count ≥ 75,000/mcL (transfusion independent); Hemoglobin ≥ 8.0 g/dL (may receive packed red blood cell transfusions)
Kidney function
adequate renal function; see laboratory inclusion
Liver function
Total bilirubin ≤ 1.5 times the upper limit of normal for age; AST (SGOT) and ALT (SGPT) 2.5 X institutional upper limit of normal; Albumin (serum or plasma) > 2 g/dL
Cardiac function
Ejection fraction of ≥ 50% by echocardiogram or MUGA
Subjects must have normal organ and marrow function as defined below: ... Adequate bone marrow function ... Adequate liver function ... Adequate cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UH Rainbow Babies & Children's Hospital · Cleveland, Ohio
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