Acute Myeloid Leukemia (AML) MedDRA version: 17.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: SGI-110
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Not available
CAS Number: 929904-85-8
Current Sponsor code: SGI-110
Other descriptive name
Sigma-Tau Pharmaceuticals)
Product Name: Cytarabine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Cytarabine
Other descriptive name: CYTARABINE
Concentration unit: mg/ml milligram
Sponsors
Astex Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must fulfill all of the following inclusion criteria. 1. Able to understand and comply with study procedures, and provides written informed consent before any study-specific procedure. 2. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to the 2008 World Health Organization (WHO) classification (bone marrow or peripheral blood blast counts =20%). 3. Performance status (ECOG) of 0-3. 4. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed. 5. Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER: a. =75 years of age OR b. 3 × upper limit of normal (ULN). iv. Other contraindication(s) to anthracycline therapy (must be documented). v. Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization. 6. Creatinine clearance as estimated by the Cockroft-Gault (C-G) or other medically acceptable formulas =30 mL/min. 7. Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures during the study and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving treatment with SGI-110 and for at least 3 months after completing treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 720
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria will be excluded from the study: 1. Candidate for intensive remission induction chemotherapy at the time of enrollment. 2. Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators. 3. Known extramedullary central nervous system (CNS) AML. 4. Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy. 5. Prior treatment with decitabine or azacitidine. 6. Hypersensitivity to decitabine, azacitidine, cytarabine, SGI-110, or any of their excipients. 7. Treated with any investigational drug within 2 weeks of the first dose of study treatment. 8. Total serum bilirubin >2.5 × ULN, except for subjects with Gilbert's Syndrome for whom direct bilirubin is 2 liters per minute (LPM) oxygen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess and compare efficacy (complete response [CR] rate) and overall survival (OS) between SGI-110 and TC (treatment choice) in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.;Secondary Objective: To assess and compare effects of SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy with respect to the following variables: - Composite CR (CRc = CR + Complete response with incomplete blood count recovery [CRi] + Complete response with incomplete platelet recovery [CRp]) rate. - Number of days alive and out of the hospital - Progression-free survival (PFS). - Transfusion needs. - Health-related quality of life (QOL). - Duration of CR. - Safety;Primary end point(s): Co-primary Endpoints • Complete Response CR rate based on modified International Working Group (IWG) 2003 AML Response Criteria. • Overall Survival OS, defined as the number of days from randomization to death.;Timepoint(s) of evaluation of this end point: After randomization, visits will occur on every treatment day. In addition, Weekly visits will occur on Days 8, 15, and 22 of the first 2 cycles of therapy and on Day 15 only in Cycles 3-6. In Cycles >6, only the treatment day visits are required, with hematology blood draws on Day 1 only. Additional visits based on treatment effect and blood counts may be done at the investigator’s discretion. Subjects will attend a safety follow-up visit after the last study treatment. For subjects who discontinue study treatment before Cycle 6, long-term follow-up visits will occur monthly until 6 months after the start of study treatment and then every 3 months thereafter. For subjects who discontinue study treatment after Cycle 6, long-term follow-up will be every 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • CRc (CR+CRi+CRp) rate. • Number of days alive and out of the hospital. • PFS, defined as the number of days from randomization to disease progression or death, whichever occurs first. • Number of red blood cell (RBC) or platelet transfusions (units) over the duration of the study treatment. • Health-related QOL by EQ-5D (consisting of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale [EQ VAS]). • Duration of CR, defined as the time from first CR to time of relapse. • Incidence and severity of adverse events (AEs). • 30- and 60-day all-cause early mortality.;Timepoint(s) of evaluation of this end point: Defined in the protocol | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical trial info SGI-110-4
Astex Pharmaceuticals, Inc.
Outcome results
None listed