OncoMatch/Clinical Trials/NCT07477457
A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma
Is NCT07477457 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for osteosarcoma.
Treatment: Methotrexate · Doxorubicin · Cisplatin · Gefitinib · Trametinib · Disulfiram · Sunitinib · Ifosfamide — The researchers are doing this study to find out whether adding gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy is a more effective treatment approach for people with osteosarcoma than standard chemotherapy on its own. The researchers will also look at the safety of adding these drugs to standard chemotherapy. The researchers will also use the additional research biopsies from Cohort 1 participants to learn more about how osteosarcoma survives during chemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Osteosarcoma
Disease stage
Metastatic disease required
Demographics
Prior therapy
Must have received: systemic conventional chemotherapy (MAP (AP x 1 and HDMTX up to 2 times)) — newly diagnosed (Cohort 1)
Having received a single standard MAP cycle (AP x 1 and HDMTX up to 2 times) of chemotherapy prior to enrollment is acceptable
Must have received: ifosfamide-containing conventional chemotherapy (ifosfamide) — relapsed (Cohort 2)
Patients may have received only a single cycle of ifosfamide-containing conventional chemotherapy ever and included for the relapse making them eligible for OstEvo
Cannot have received: cardiac irradiation
Patients may not have received prior cardiac irradiation
Lab requirements
Blood counts
Absolute neutrophil count > 250 cells/mcL; Platelet count > 50,000/mcL
Kidney function
creatinine clearance (estimated or by cystatin C) or radioisotope GFR > 70 mL/min/1.73m2 or estimated GFR (eGFR) in pediatric patients; serum creatinine based on age/sex (use the Schwartz formula for estimating GFR)
Liver function
Total bilirubin < 1.5 x ULN for age; AST and ALT < 3 x ULN for age
Cardiac function
No history of congenital prolonged QTc syndrome; QTcF < 480 msec; Left ventricular ejection fraction (LVEF) > 55% on echocardiogram or MUGA
Adequate Hematologic function, defined as: Absolute neutrophil count > 250 cells/mcL; Platelet count > 50,000/mcL. Adequate Renal Function, defined as: creatinine clearance (estimated or by cystatin C) or radioisotope GFR > 70 mL/min/1.73m2 or estimated GFR (eGFR) in pediatric patients; serum creatinine based on age/sex (use the Schwartz formula for estimating GFR). Adequate Liver Function, defined as: Total bilirubin < 1.5 x ULN for age; AST and ALT < 3 x ULN for age. Adequate Cardiac Function, defined as: No history of congenital prolonged QTc syndrome; QTcF < 480 msec; Left ventricular ejection fraction (LVEF) > 55% on echocardiogram or MUGA
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering at Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering at Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering at Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07477457 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cardiac irradiation disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 49 years or younger and at least 6 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages