Phase 1 Study of SGI-110 in Patients With Acute Myeloid Leukemia

NCT ID: NCT02293993

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-07
• Study Completion Date: 2019-05-31

Brief Summary

To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously to Japanese patients with acute myeloid leukemia (AML).

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort1

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).

Group Type: EXPERIMENTAL

SGI-110

Intervention Type: DRUG

Cohort2

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).

Group Type: EXPERIMENTAL

SGI-110

Intervention Type: DRUG

Cohort3

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).

Group Type: EXPERIMENTAL

SGI-110

Intervention Type: DRUG

Cohort4

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).

Group Type: EXPERIMENTAL

SGI-110

Intervention Type: DRUG

Interventions

SGI-110

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junji Ikeda

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

kinki Region

Kyoto, , Japan

Kanto

Region, , Japan

Kyusyu

Region, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

JapicCTI-142711

Identifier Type: OTHER

Identifier Source: secondary_id

343-14-001

Identifier Type: -

Identifier Source: org_study_id