drugset / Trial / NCT01362036

Phase I Study Evaluating TXA127 in Low/Intermediate-1 Risk Myelodysplastic Syndrome and Thrombocytopenia

NCT01362036

Phase 1 Terminated 2 enrolled Tarix Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

Phase 1, single-center, open-label, sequential cohort dose escalation study. This is a 3 + 3 design study involving at least 3 subjects in ascending dose cohorts, with subjects participating up to 10 weeks. The overall study objectives are to evaluate the safety and tolerability of TXA127 in thrombocytopenic subjects with low or intermediate-1 risk MDS. Evaluation of the platelet response and the erythroid and granulocytic responses to TXA127 will provide preliminary efficacy data.

Timeline

Start
2011-04
Primary completion
2012-04
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject talfirastide Peptide 300 ug/kg Subcutaneous
Subject talfirastide Peptide 600 ug/kg Subcutaneous
Subject talfirastide Peptide 900 ug/kg Subcutaneous