Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
Recruiting
Phase 1
Phase 2
Interventional Study
Sarcoma
Osteosarcoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 40
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 74 (estimated)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 performa…
Contacts