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Domatinostat with Sirolimus for Relapsed or Refractory Sarcoma and Osteosarcoma

This study is testing a combination of two drugs, domatinostat and sirolimus, for adolescents and young adults (ages 12-40) with sarcoma or osteosarcoma that has come back or not responded to previous treatments. Researchers want to understand if this drug combination is safe, how well your body handles it, and if it can help shrink tumors. The study will measure the highest safe dose of the drugs (Phase 1) and how long people live without their cancer getting worse (Event Free Survival) for up to 12 months (Phase 2). This study is currently unclear on its recruitment status.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll 74 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track how long participants live without their cancer getting worse for up to 12 months in one group and up to 4 months in another group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07725380

Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma

Recruiting
PHASE1Ages 12–40InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~74 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:DomatinostatSirolimus

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Maximum Tolerated Dose (MTD)
Measured over 28 days
+2 more outcomes measured

Conditions

Sarcoma
Osteosarcoma

Explore related trials

OsteosarcomaSarcoma

Where it's being run

4 sites across 4 states
Florida1
Missouri1
New York1
Ohio1

Study leadership

  • Amy Armstrong, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
  • Jonathan Metts, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Jessica Crimella
[email protected]
813-745-6250
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Phase 1: Maximum Tolerated Dose (MTD)28 days

    For the phase 1 portion, a standard 3+3 design will be used to determine the MTD and/or RP2D for the Phase 2 portion of this study.

  • Phase 2: Arm A Event Free Surival12 months

    Event free survival (EFS) is defined as the duration of time from start of treatment to time of disease progression, secondary malignancy, or death, whichever occurs first.

  • Phase 2: Arm B Event Free Surival4 months

    Event free survival (EFS) is defined as the duration of time from start of treatment to time of disease progression, secondary malignancy, or death, whichever occurs first.