A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma
OstEvo - Osteosarcoma Evolves
1 other identifier
interventional
45
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2026
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2026
CompletedFirst Submitted
Initial submission to the registry
March 12, 2026
CompletedFirst Posted
Study publicly available on registry
March 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 11, 2028
March 17, 2026
March 1, 2026
2 years
March 12, 2026
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
12-month progression free survival (PFS) (cohort 1)
Response will be determined by the investigator and progression will be guided by RECIST 1.1 criteria
12 months
24-month overall survival (OS) (cohort 2)
Response will be determined by the investigator and progression will be guided by RECIST 1.1 criteria
24 months
Study Arms (3)
Newly Diagnosed, Metastatic Osteosarcoma
EXPERIMENTALPatient will receive study treatment that includes standard MAP chemotherapy in addition to either gefitinib, trametinib, disulfiram, or sunitinib, or a combination of some of these drugs. Participants will receive the study treatment during 6 treatment Cycles. Each Cycle will last 28 days.
Relapsed, Metastatic Osteosarcoma
EXPERIMENTALPatient will receive study treatment that includes standard ifosfamide chemotherapy in addition to either gefitinib, trametinib, disulfiram, or sunitinib, or a combination of some of these drugs. Participants will receive the study treatment during 6 treatment Cycles. Each Cycle will last 21 days.
Newly Diagnosed Osteosarcoma
EXPERIMENTALResearch Biopsy only
Interventions
Methotrexate 12 g/m\^2 (max dose 20 grams) intravenously over 4 hours or as per institutional standard.
Doxorubicin 37.5 mg/m\^2 intravenously over 15 to 30 minutes or as per institutional standard.
Cisplatin 60 mg/m\^2 intravenously over 4 hours or as per institutional standard.
Gefitinib 400 mg/m\^2/dose (maximum dose 250 mg) orally daily for 14 days (14 doses)
Trametinib will be dispensed as per institutional standard.
Disulfiram 250 to 500 mg orally once daily for 14 days
Sunitinib capsules for under 18 years of age: 15 mg/m\^2/dose (maximum 50 mg) orally once daily x 14 days
Ifosfamide 2,800 mg/m\^2 intravenously as per institutional standard.
Eligibility Criteria
You may qualify if:
- Cohort 1 only: Newly Diagnosed, Metastatic Osteosarcoma
- For study entry, the suspected diagnosis of osteosarcoma may be based on clinical judgement. Biopsy confirmation is required for treatment but as this protocol has biologic aims from serial tumor samples, some patients will be enrolled prior to open biopsy. Patients must have a histologic new diagnosis of metastatic high-risk osteosarcoma to start OstEvo systemic therapy. For purposes of this protocol, newly diagnosed, high-risk metastatic osteosarcoma includes:
- Having at least 1 extrapulmonary metastasis, radiographic confirmation of metastasis is adequate, and/or
- Unresectable metastases at diagnosis as determined by the investigator
- Patients may have started systemic conventional chemotherapy but must enroll on this study prior to day 29 of chemotherapy initiation. Having received a single standard MAP cycle (AP x 1 and HDMTX up to 2 times) of chemotherapy prior to enrollment is acceptable
- Cohort 2 only: Relapsed, Metastatic Osteosarcoma
- \. Patients must have achieved a radiographically confirmed complete response as determined by the investigator from initial therapy and then relapsed with metastatic high-risk osteosarcoma. No strict size criteria of pulmonary or additional nodules for eligibility are required. For purposes of this protocol, relapsed, metastatic, high-risk osteosarcoma includes:
- a. First relapse within 24 months of start of first chemotherapy or b. First relapse involving more than one lung nodule, or the lung and any extrapulmonary sites or c. First relapse with pleural disruption at relapse as determined by the investigator which can be determined by CT scan and/or d. Multiply relapsed patients are eligible provided the current relapse is in the context of a radiographically confirmed complete response on the scans preceding the relapse making them potentially eligible for OstEvo 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, but must enroll on this study prior to day 22 of the first cycle post-relapse
- Cohort 3 only
- Patients with newly diagnosed osteosarcoma who are not eligible for Cohorts 1 or 2.
- Diagnostic biopsy has insufficient material for research.
- Must be enrolled on MSK IRB 12-245, biospecimen research protocol, with oncologic surgeries planned to be performed at MSK.
- Orthopedic surgeon assessment is that a research biopsy will not increase the risk of local recurrence.
- Patients must be willing to assent, and consenting party must consent to the single research biopsy prior to the initiation of chemotherapy. Patients over 18 must consent to research biopsies at study entry.
- Cohorts 1 and 2 only
- +12 more criteria
You may not qualify if:
- Cohorts 1 and 2 only:
- Patients who are receiving any other investigational agents for osteosarcoma therapy are ineligible.
- Patient with an uncontrolled chronic or active infection or another condition where any component of OstEvo therapy would be contraindicated.
- Patients with a history of heart disease including, but not limited to: uncontrolled hypertension within 12 months prior to enrollment; ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade; unstable angina, symptomatic congestive heart failure, or prior myocardial infarction.
- Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of oral agents.
- Patients may not have received prior cardiac irradiation.
- Cohort 2 only:
- \. Patients must not have previously been enrolled in OstEvo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damon Reed, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2026
First Posted
March 17, 2026
Study Start
March 11, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 11, 2028
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.