Know Cancer

forgot password

A Phase 1/2, Open-Label, Multi-Center Dose Escalation, Safety and Tolerability Study of AKN-028 in Patients With Acute Myelogenous Leukemia (AML)

Phase 1/Phase 2
18 Years
Open (Enrolling)
Acute Myeloid Leukemia

Thank you

Trial Information

A Phase 1/2, Open-Label, Multi-Center Dose Escalation, Safety and Tolerability Study of AKN-028 in Patients With Acute Myelogenous Leukemia (AML)

This is an open-label Phase 1/2 study of AKN-028 in patients with AML. Patients with
adequate organ function, as defined in eligibility criteria, who have either relapsed after
previous induction chemotherapy or are ineligible for initial or further induction
chemotherapy will be included into the study. The study will be conducted in Europe and

Inclusion Criteria:

- Provide written informed consent prior to Screening;

- Male or female patients, age ≥ 18 years;

- For females of childbearing potential, a negative urine pregnancy test must be

- Confirmed diagnosis of AML

- Performance status of 0-3 on the Eastern Cooperative Oncology Group (ECOG)
Performance Status Scale;

- Adequate organ function, including the following:

- Serum creatinine ≤ 2.0 mg/dL (176.8 mMol/L) during screening;

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x the
upper limits of normal (ULN) during screening; and

- Total bilirubin ≤1.5 x ULN during screening.

Exclusion Criteria:

- Patients who are candidates for induction chemotherapy for AML

- Total WBC count ≥ 60,000/mm3;

- Evidence of active central nervous system (CNS) leukemia;

- Evidence of blast-phase chronic myelogenous leukemia (CML);

- Histological or cytogenetic diagnosis of AML with M3 subtype (Acute Promyelocytic

- Lack of recovery of non-hematological toxicity from systemic therapy for the
underlying hematologic condition;

- Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in
situ carcinoma of the cervix, or other solid tumor treated curatively, and without
evidence of recurrence for at least 2 years prior to study entry; this exclusion does
not refer to the disease (AML) under study;

- Uncontrolled systemic infection (viral, bacterial, or fungal);

- Uncontrolled disseminated intravascular coagulation;

- Known positive serology for human immunodeficiency virus;

- Clinically significant cardiac dysfunction (New York Heart Association Class 3 or 4)
at the time of screening, or a history of myocardial infarction or heart failure
within 3 months preceding the first dose of AKN-028;

- Chronic Graft versus Host Disease (GVHD) with the exception of mild (Grade 1) skin

- Major surgery within the 28 days preceding the first dose of AKN-028;

- Concomitant administration of any other anti-leukemia or anti-neoplastic therapy
(hydroxyurea is allowed for ≤ 7 days before Cycle 1, as well as for ≤ 7 days between

- Concomitant treatment with immunotherapy, or any investigational agent within 28 days
preceding the first dose of AKN-028, or lack of recovery from toxicity of such

- Active autoimmune disease requiring immunosuppressive therapy;

- Radiotherapy, or lack of recovery of any radiotherapy-related acute toxicity, within
the 28 days preceding the first dose of AKN-028;

- Previous treatment in any clinical study with AKN-028, any other FLT-3 inhibitor, or
any other c-Kit inhibitor;

- Female patients who are pregnant or breast-feeding;

- Male, or female patients of childbearing potential, unwilling to use an approved,
effective means of contraception (e.g., oral contraception, barrier contraception,
intrauterine device) in accordance with the investigator's standards;

- Known current drug or alcohol abuse;

- Active viral Hepatitis B and /or C;

- Other severe, acute, or chronic medical or psychiatric condition, or laboratory
abnormality that, in the opinion of the investigator, may compromise the safety of
the patient during the study, affect the patient's ability to complete the study, or
interfere with interpretation of study results;

- Any condition, which is judged by the Investigator to be inappropriate for study
participation, including an inability to communicate or cooperate with the
Investigator and the requirements of this study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Plasma pharmacokinetic profiles

Outcome Time Frame:

up to 3 months

Safety Issue:


Principal Investigator

Martin Höglund, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept of Hematology, Uppsala University Hospital


Czech Republic: State Institute for Drug Control

Study ID:




Start Date:

December 2011

Completion Date:

June 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute myeloid leukemia
  • Refractory Acute myeloid leukemia
  • FLT3 inhibitor
  • kinase inhibitor
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid