NCT00892190

Study of Dasatinib and All-Trans Retinoic Acid for Relapsed/Refractory and/or Elderly Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome

A Phase 1, Open-label, Dose-escalation Study of Dasatinib and All-Trans Retinoic Acid for Relapsed/Refractory and/or Elderly Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, prospective, single institution dose-escalation study. The patient population includes non-induction candidate elderly patients with AML or MDS and/or patients with high-risk or relapsed/refractory AML or MDS. Five dose cohorts will be evaluated using a fixed dose of ATRA in combination with an escalating dose of dasatinib. The investigators will treat with an escalating dose of dasatinib from 70mg to 140mg daily. Dose escalation will proceed in a standard 3+3 fashion. A de-escalation to a 50 mg total daily dose of dasatinib is planned if DLT is greater than or equal to 33% is observed at the first dose level. Once the MTD for the combination of the drugs has been established, up to 6 additional patients will be enrolled at the MTD level to obtain additional safety information about the combination and to allow for preliminary laboratory correlate analysis.

Detailed description

Primary Objective: 1\. To determine the safety and tolerability of the combination of dasatinib and ATRA in relapsed or elderly, non-induction candidate acute myelogenous leukemia (AML) or MDS patients and to identify the maximally tolerated dose (MTD), dose-limiting toxicities (DLT). Secondary Objectives: 1. To determine the pharmacokinetic (PK) profiles of dasatinib and ATRA when administered as combination therapy for patients with AML or MDS 2. To determine if the combination therapy of dasatinib and ATRA promotes differentiation of AML or MDS .

Conditions

• Acute Myelogenous Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	dasatinib (SPRYCEL)	DL0 - 50 mg every 24 hours DL1 (START)- 70 mg every 24 hours DL2 - 100 mg every 24 hours DL3 - 140 mg every 24 hours
DRUG	all trans retinoic acid (VESANOID)	22.5mg/m2 every 12 hours

Timeline

• Start date: 2011-04-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2009-05-04
• Last updated: 2016-02-10

Locations

1 site across 1 country: United States