Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-40
SponsorH. Lee Moffitt Cancer Center and Research Institute
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Receiving another investigational agent.
Receiving concurrent anticancer therapy.
Known hypersensitivity to domatinostat or sirolimus.
Bone marrow-only disease.
Trial design
Treatments tested in this trial
- Domatinostat
- Sirolimus
Treatment groups
74 Participants
are divided into 3 treatment groupsSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
National Pediatric Cancer Foundation
Collaborator
Healx USA, Inc
Collaborator
Source ClinicalTrials.gov