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Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MSX-122 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSX-122 | Drug | 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.)
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122 | 12 Months Estimated | |
| Characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122 | 12 Months Estimated |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122 | 12 Months Estimated | |
| Evaluate the preliminary evidence for anti-tumor activity of MSX-122 | 12 Months Estimated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer J. Wheler, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.T.M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| C573792 | N,N'-(1,4-phenylenebis(methylene))dipyrimidin-2-amine |
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| 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) | 12 Months Estimated |