Domatinostat with Sirolimus for relapsed or refractory sarcoma and osteosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 1/2 trial evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of the combination of domatinostat and sirolimus in patients aged 12 to 40 with relapsed or refractory sarcoma or osteosarcoma. Phase 1 will assess dose-limiting toxicities and establish a recommended dose, while Phase 2 will explore preliminary efficacy signals. Eligible participants have had at least one prior systemic therapy and meet organ function and performance criteria; other treatments and recent surgeries may exclude enrollment. The study is led by H. Lee Moffitt Cancer Center with collaboration from the National Pediatric Cancer Foundation and Healx, and is conducted at multiple centers in the United States.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Not yet recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Not yet recruiting

Study contacts

• Principal investigator: Amy Armstrong, MD — Washington University School of Medicine
• Study coordinator: Jessica Crimella
• Email: Jessica.Crimella@moffitt.org
• Phone: 813-745-6250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.