Phase I trial of the combination of bortezomib and clofarabine in adults with refractory tumors - PubMed
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- #Bortezomib
- #Clofarabine
- #Phase I trial
- Phase I trial evaluated bortezomib and clofarabine combination in refractory tumors.
- Primary objective: assess safety, tolerability, and MTD in solid tumors, lymphomas, or MDS.
- Secondary objective: examine effects on biomarkers of cell death and DNA damage response.
- MTD for solid tumors: 1.3 mg/m² bortezomib (days 1,4) and 1.5 mg/m² clofarabine (days 1-5).
- 11 out of 28 patients achieved stable disease; 5 had stable disease for ≥6 cycles.
- Most common adverse events were hematologic.
- Limited antitumor effects observed, possibly due to inability to reach preclinical efficacious doses.