Safety and Tolerability of AZD1208 and the Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients
Status: Recruiting
Phase:
Diagnosis: Leukemia/MDS
NCT ID: NCT01489722
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-461
The purpose of this open label study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AZD1208 in patients with recurrent or refractory Acute Myelogenous Leukemia (AML). This study will have two parts. In Part A, patients will receive escalating doses to identify the maximum tolerated dose (MTD). In Part B, the efficacy of the maximum tolerated dose will be evaluated in a expanded group of patients with selected biomarker.
Conducting Institutions:
Dana-Farber Cancer Institute
Overall PI:
Daniel DeAngelo, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
igalinsky@partners.org
Eligibility Criteria
Inclusion Criteria:
- Males or females at least 18 years of age
- Patients with relapsed or refractory Acute myelogenous leukemia (AML) or AML
secondary to myelodysplastic syndromes, myeloproliferative neoplasm, or chronic
myelogenous leukemia
- Part B only: AML with no more than two prior salvage regimens
- Part B only: Patients positive for a select tumor marker
- Eastern Oncology Cooperative Group (ECOG) performance status 0-2 and considered
likely to complete at least 4 weeks of therapy
Exclusion Criteria:
- With the exception of alopecia, any unresolved toxicities from prior therapy greater
than CTCAE grade 1 at the time of starting study treatment.
- As judged by the investigator, any evidence of severe or uncontrolled systemic
diseases, including uncontrolled hypertension, active bleeding diatheses, or active
infection including hepatitis B, hepatitis C and HIV.
- Active heart disease including myocardial infarction within the last 3 months,
symptomatic coronary artery disease, clinically significant arrhythmias not
controlled by medication or uncontrolled congestive heart failure
- Prior allogeneic transplant requiring immunosuppressive therapy (Patients with prior
allogeneic transplants who remain clinically stable for ≥ 2 weeks or more off
immunosuppressive therapy, are eligible)
- White blood cell count ≥ 100,000/mm3