NCT07477457

A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma

OstEvo - Osteosarcoma Evolves

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 6 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteosarcoma
• Metastasis

Interventions

Type	Name	Description
DRUG	Methotrexate	Methotrexate 12 g/m\^2 (max dose 20 grams) intravenously over 4 hours or as per institutional standard.
DRUG	Doxorubicin	Doxorubicin 37.5 mg/m\^2 intravenously over 15 to 30 minutes or as per institutional standard.
DRUG	Cisplatin	Cisplatin 60 mg/m\^2 intravenously over 4 hours or as per institutional standard.
DRUG	Gefitinib	Gefitinib 400 mg/m\^2/dose (maximum dose 250 mg) orally daily for 14 days (14 doses)
DRUG	Trametinib	Trametinib will be dispensed as per institutional standard.
DRUG	Disulfiram	Disulfiram 250 to 500 mg orally once daily for 14 days
DRUG	Sunitinib	Sunitinib capsules for under 18 years of age: 15 mg/m\^2/dose (maximum 50 mg) orally once daily x 14 days
DRUG	Ifosfamide	Ifosfamide 2,800 mg/m\^2 intravenously as per institutional standard.
PROCEDURE	Biopsy	Research biopsy prior to therapy

Timeline

• Start date: 2026-03-11
• Primary completion: 2028-03-01
• Completion: 2028-03-11
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study