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New treatment option for Sarcoma
Official title Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
ClinicalTrials.gov ID: NCT07725380
What this study is testing
What is Domatinostat?
Domatinostat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, open-label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma and osteosarcoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 40
You may be able to join if
- Age ≥12 and ≤40 years.
- Histologically confirmed relapsed or refractory sarcoma (Phase 1) or osteosarcoma (Phase 2).
- At least one prior standard systemic therapy regimen.
- Not candidates for available therapies known to provide survival benefit.
- Karnofsky/Lansky performance score ≥60.
You likely can't join if
- Receiving another investigational agent.
- Receiving concurrent anticancer therapy.
- Known hypersensitivity to domatinostat or sirolimus.
- Bone marrow-only disease.
- CNS metastatic disease.
- Major surgery within 2 weeks prior to treatment.
See the full eligibility criteria
- Age ≥12 and ≤40 years.
- Histologically confirmed relapsed or refractory sarcoma (Phase 1) or osteosarcoma (Phase 2).
- At least one prior standard systemic therapy regimen.
- Not candidates for available therapies known to provide survival benefit.
- Karnofsky/Lansky performance score ≥60.
- Life expectancy ≥16 weeks.
- Adequate organ function: ANC ≥1,000/mcL, Platelets ≥100,000/uL, Hemoglobin ≥8 g/dL, Adequate hepatic and renal function.
- Ability to swallow tablets.
- Negative pregnancy test for females of childbearing potential.
- Agreement to use effective contraception.
- Ability to provide informed consent/assent.
- Receiving another investigational agent.
- Receiving concurrent anticancer therapy.
- Known hypersensitivity to domatinostat or sirolimus.
- Bone marrow-only disease.
- CNS metastatic disease.
- Major surgery within 2 weeks prior to treatment.
- Active malignancy within the previous 3 years (with protocol-specified exceptions).
- History of solid organ transplantation.
- Significant recent cardiac disease.
- Concurrent prohibited CYP3A4/P-gp interacting medications.
- Uncontrolled infection or other serious uncontrolled illness.
- Pregnancy or breastfeeding.
- HIV infection on antiretroviral therapy.
- Weight \<40 kg.
- Inability to comply with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- St Louis, Missouri, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; St Louis, Missouri, United States; The Bronx, New York, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.