Overview

Condition acute myeloid leukemia
Treatment sgi-110
Phase phase 1
Sponsor Otsuka Pharmaceutical Co., Ltd.
Start date October 2014
End date May 2017
Trial size 14 participants
Trial identifier NCT02293993, 343-14-001

Summary

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
Other Countries Japan

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SGI-110 36mg/m2 will be administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
sgi-110
(Experimental)
SGI-110 60mg/m2 will be administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
sgi-110
(Experimental)
SGI-110 90mg/m2 will be administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
sgi-110
(Experimental)
SGI-110 60mg/m2 will be administered subcutaneously once daily for 10 days (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28).
sgi-110

Primary Outcomes

Measure
Dose Limiting Toxicity
time frame: 28days

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

Official title Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..