Safety Study of AKN-028 in Patients With Acute Myelogenous Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Akinion Pharmaceuticals AB.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Akinion Pharmaceuticals AB
ClinicalTrials.gov Identifier:
NCT01573247
First received: March 28, 2012
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML). The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: AKN-028
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Multi-Center Dose Escalation, Safety and Tolerability Study of AKN-028 in Patients With Acute Myelogenous Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Akinion Pharmaceuticals AB:

Primary Outcome Measures:
  • Plasma pharmacokinetic profiles [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]
    Safety follow up


Secondary Outcome Measures:
  • Response [ Time Frame: participants will be followed for the duration of up to 3 months ] [ Designated as safety issue: No ]
    Biological respons


Estimated Enrollment: 35
Study Start Date: December 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AKN-028 Drug: AKN-028
Part 1 of the study is a sequential dose-escalation evaluation of AKN-028. During Part 2 of the study AKN-028 will be administered at the dose level selected in Part 1. Patients will be treated for a maximum of 3 cycles of 21 days, with at least a 7-day treatment-free period between cycles.

Detailed Description:

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 Russia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 obtained
  • 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 Leukemia);
  • 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 GVHD;
  • 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 cycles);
  • 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 treatment;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573247

Contacts
Contact: Maria Klockare +46 852486879 maria.klockare@akinion.com

Locations
Czech Republic
University Hospital Brno Recruiting
Brno, Czech Republic, 625 00
University Hospital Kralovske Vinohrady Not yet recruiting
Prague, Czech Republic, 100 34
Poland
Institute of Hematology and Transfusion Medicine Not yet recruiting
Warsaw, Poland, 02-776
MTZ Clinical Research Sp. z o.o. Not yet recruiting
Warsaw, Poland, 02-106
Russian Federation
Moscow State Medical Institution City Clinical Hospital n.a. S.P. Botkin Not yet recruiting
Moscow, Russian Federation, 125284
St. Peterburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development Not yet recruiting
St. Petersburg, Russian Federation, 197022
Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, SE-751 85
United Kingdom
St.Bartholomew's Hospital Not yet recruiting
West Smithfield, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Akinion Pharmaceuticals AB
Investigators
Principal Investigator: Martin Höglund, MD, PhD Dept of Hematology, Uppsala University Hospital
  More Information

No publications provided by Akinion Pharmaceuticals AB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Akinion Pharmaceuticals AB
ClinicalTrials.gov Identifier: NCT01573247     History of Changes
Other Study ID Numbers: AKN001, 2011-003285-33
Study First Received: March 28, 2012
Last Updated: April 16, 2012
Health Authority: Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
Poland: The Central Register of Clinical Trials
Poland: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Akinion Pharmaceuticals AB:
Acute myeloid leukemia
Refractory Acute myeloid leukemia
FLT3 inhibitor
kinase inhibitor

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014