Primary Objectives: 1. To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122 2. To characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122 Secondary Objectives: 1. To determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122 2. To evaluate the preliminary evidence for anti-tumor activity of MSX-122 3. To perform correlative studies to elucidate signaling pathways involved in CXCR4 activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA (reverse phase protein microarrays)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Dosage form = capsule Starting Dose (First Patient Cohort - Dose Level 1) = 50 mg taken orally once daily, 7 days per week for 4 weeks (total of 28 days), followed immediately by a second course of 28 days with identical dosage form and schedule. (Each patient in each cohort treated for a minimum of 56 days, unless obviated by toxicity.) * If there is no evidence of toxicity at the current dose level, then the dose of MSX-122 will be increased by 100% for the next patient cohort. * If a grade 1-2 toxicity is observed, then the dose will be increased by 50% for the next patient cohort. * If a grade 3 toxicity (non-dose limiting toxicity) is observed then the dose will be increased by 25% for the next patient cohort.
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States
Determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122
Time frame: 12 Months Estimated
Characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122
Time frame: 12 Months Estimated
Determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122
Time frame: 12 Months Estimated
Evaluate the preliminary evidence for anti-tumor activity of MSX-122
Time frame: 12 Months Estimated
Perform correlative studies to elucidate signaling pathways involved in CXCR4 activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA (reverse phase protein microarrays)
Time frame: 12 Months Estimated
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