Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) 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: 27.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) M
Conditions
Interventions
Product Name: ASTX727 (decitabine and cedazuridine)
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
Taiho Oncology, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Previous participation in an Astex / Taiho-sponsored ASTX727 clinical trial (including but not limited to studies ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17 and ASTX727-18, and the food effect substudy of ASTX727-06) 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 the Sponsor. 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 (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.) 3) Subject is able to understand and comply with the study procedures and understands the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 must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control (with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 72
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
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable ;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide ongoing long-term treatment with ASTX727 for subjects who were benefiting from ASTX727 treatment in a previous Astex/Taiho-sponsored clinical study. To obtain long-term safety information.;Secondary Objective: Not applicable;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 | — |
Countries
Armenia, Austria, Bulgaria, Canada, European Union, Germany, Hungary, Italy, Lithuania, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactRegulatory Affairs
Taiho Oncology, Inc.
Outcome results
None listed