Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors MedDRA version: 21.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classifi
Conditions
Interventions
Product Name: ASTX727 (cedazuridine and decitabine)
Product Code: ASTX727
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DECITABINE
CAS Number: 2353-33-5
Current Sponsor code: DAC, DCT-0
Sponsors
Astex Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Previous participation in an Astex-sponsored ASTX727 clinical trial (including but not limited to studies ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17, ASTX727-18) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex. 2) Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion. (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.) 3) Subject is able to understand and comply with the study procedures and understands the risks involved in the study. 4) Subject provides legally effective informed consent before undergoing any study-specific procedure. 5) Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6 months after completing treatment. 6) Men with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure (user dependent or with low user dependency) while receiving treatment with ASTX727 for at least 3 months after completing treatment and must agree not to father a child while receiving study treatment for at least 3 months after completing ASTX727 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: 1) Any subject who, in the opinion of the investigator, may have other conditions or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide ongoing long-term treatment with ASTX727 for subjects who were benefitting from ASTX727 treatment in a previous Astex-sponsored clinical study.;Secondary Objective: To obtain information on survival and disease status, including conversion to AML (subjects with hematological malignancy only).;Primary end point(s): Safety as measured by AEs;Timepoint(s) of evaluation of this end point: AE monitoring - Day 1 of each cycle and at Safety Follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Survival and disease status, including conversion to AML (subjects with hematological malignancy only).;Timepoint(s) of evaluation of this end point: Survival and disease status assessment - quaterly until death or until subject withdrawal from the study | — |
Countries
Canada, European Union, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactRegulatory Affairs
Astex Pharmaceuticals, Inc.
Outcome results
None listed