drugset
drugset / Trial / NCT02873338

Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

NCT02873338 ↗

Phase 2 Completed 75 enrolled Jazz Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.

Timeline

Start
2016-08
Primary completion
2019-06
Completion
2019-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dociparstat Other / unclassified 0.125 mg/kg Intravenous
Subject Dociparstat Other / unclassified 0.25 mg/kg Intravenous
Background Cytarabine Small molecule 100 mg/m2 Intravenous
Background Idarubicin Small molecule 12 mg/m2 Intravenous

Indications

acute myeloid leukemia