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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Tablet
Tablet
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGWashington University in St. Louis
St Louis, Missouri, United States
NOT_YET_RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
NOT_YET_RECRUITINGPhase 1: Maximum Tolerated Dose (MTD)
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.
Time frame: 28 days
Phase 2: Arm A Event Free Surival
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.
Time frame: 12 months
Phase 2: Arm B Event Free Surival
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.
Time frame: 4 months
Phase 2: Overall Survival
Overall Survival (OS) of phase 2 participants.
Time frame: Up to 5 years
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Nationwide Children's Hospital
Columbus, Ohio, United States
RECRUITING