The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902 identified in the phase 1 to treat subjects with triple negative breast cancer.
In this dose-finding, open-label, single-agent study of RX-5902, subjects will be treated for up to 6 cycles of therapy. RX-5902 will be administered orally daily for 3 weeks followed by 1 week of rest in each cycle. All subjects will be followed for at least 30 days after the last dose of study agent for safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
escalating doses (mg)
Rexahn site
Tucson, Arizona, United States
Rexahn Site
Aurora, Colorado, United States
Rexahn site
Chicago, Illinois, United States
Rexahn Site
Detroit, Michigan, United States
Incidence of dose limiting toxicities (DLTs) (Phase 1)
Time frame: after 4 weeks of treatment with RX-5902
Progression free survival rate and/or overall clinical response rate (Phase 2)
Time frame: 16 weeks of treatment with RX-5902
Area under the plasma concentration versus time curve (AUC) of RX-5902
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 hrs after the first dose
Changes in tumor size mm
Time frame: baseline and 24 weeks
Time to progression (Phase 2)
Time frame: Baseline and at 4, 8, 12, 16 and 24 weeks
Duration of response (Phase 2)
Time frame: Baseline and at 4, 8, 12, 16 and 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rexahn Site
Hackensack, New Jersey, United States
Rexahn Site
New York, New York, United States
Rexahn Site
Greenville, South Carolina, United States
Rexahn site
Arlington, Virginia, United States