Status:
COMPLETED
A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status
Lead Sponsor:
Daiichi Sankyo
Conditions:
Acute Myeloid Leukemia
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.
Detailed Description
This is a multi-center clinical study conducted in the USA and two international sites. This open-label, dose escalation study was designed to characterize the safety, tolerability, pharmacokinetics (...
Eligibility Criteria
Inclusion
- Males and females age ≥ 18 years;
- Histopathologically documented primary or secondary AML, as defined by WHO criteria (Jaffe et al, 2001), confirmed by pathology review at treating institution, meeting at least one of the following:
- Refractory to at least 1 cycle of induction chemotherapy, or
- Relapsed after at least 1 cycle of induction chemotherapy, or
- Patient is not, according to the clinical judgment of the Principal Investigator, a candidate for induction chemotherapy due to age, comorbidity, or other factors;
- Patients for whom no standard therapies are anticipated to result in a durable remission, or who have failed potentially curative therapy, or who refuse standard therapy or patients for whom there is no known therapy of documented treatment benefit;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
- In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration should be at least 2 weeks for cytotoxic agents (other than hydroxyurea, per Section 8.8), or at least 5 half-lives for noncytotoxic agents;
- Persistent chronic clinically significant toxicities from prior chemotherapy or surgery must be less than Grade 2;
- Serum creatinine ≤ 2.0 mg/dL;
- Total serum bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's syndrome or leukemic organ involvement;
- Serum AST or ALT ≤ 3.0 × ULN unless considered due to leukemic organ involvement;
- Females of childbearing potential must have a negative pregnancy test (urine β-hCG);
- Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study;
- Written informed consent must be provided.
Exclusion
- Histologic diagnosis of acute promyelocytic leukemia;
- Clinically active central nervous system leukemia;
- Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v3);
- Bone marrow transplant within 2 months prior to study;
- Active, uncontrolled infection;
- Major surgery within 4 weeks prior to study;
- Radiation therapy within 4 weeks prior to, or concurrent with, study;
- Human immunodeficiency virus positivity;
- Active hepatitis B or C or other active liver disease;
- Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential;
- Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00462761
Start Date
January 1 2007
End Date
December 1 2009
Last Update
May 11 2020
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia