Solid Tumors Clinical Trial
Official title:
Phase I Dose Escalation Study to Determine the Safety and Pharmacokinetics of MSX-122 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
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)
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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