Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia
|Condition||acute myeloid leukemia|
|Sponsor||Otsuka Pharmaceutical Co., Ltd.|
|Start date||October 2014|
|End date||May 2017|
|Trial size||14 participants|
|Trial identifier||NCT02293993, 343-14-001|
To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously to Japanese patients with acute myeloid leukemia (AML).
Recruiting in the following locations…
|United States||No locations recruiting|
|Endpoint classification||safety study|
|Intervention model||factorial assignment|
Dose Limiting Toxicity
time frame: 28days
Pharmacokinetics measured by SGI-110 and decitabine plasma concentration.
time frame: Day 1and Day 5: Pre-dose, 15 min, 30 min, 60 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h after dosing. Day 2, 3 and 4: Pre-dose
Male or female participants at least 20 years old.
- Male or female patients with a diagnosis of AML (WHO classification 2008).
- Patients, 20 years of age or older, who are unresponsive to standard chemotherapy or have relapsed following standard chemotherapy
- Patients, 65 years of age or older, who are not eligible for standard intensive chemotherapy
- Patients with ECOG performance status (PS) of 0 to 2
- Patients with adequate organ function
- Women of child-bearing potential must not be pregnant or breast feeding (pregnancy test will be performed at Screening). Women of child bearing potential and all men with female partners of child bearing potential must practice two medically acceptable methods of birth control and must not become pregnant or father a child while receiving treatment with SGI-110 and for 3 months following last dosing.
- Patients who have undergone prior allogeneic hematopoietic stem cell transplantation must have no evidence of active graft-versus host disease (GVHD) and must be off immunosuppressive therapy by ≥2 weeks prior to IMP administration.
- Patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or (PML/RARA) karyotype abnormalities (include other variant types of APL)
- Patients with multiple cancers (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 3 years)
- Subjects with life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk.
- Patients with poorly controlled arrhythmias, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Patients with symptomatic central nervous system involvement.
|Official title||Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia|
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