Health Condition 1: D469- Myelodysplastic syndrome, unspecified
Conditions
Interventions
Intervention1: AZADINE® of Intas Pharmaceuticals Limited, India: Dose: 75 mg/m2
Frequency: Daily for 7 days in each 28-day cycle
Mode of
Administration: subcutaneously
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of greater than or equal to 18 years of age at the time of signing the informed consent document 2. Histologically or cytologically documented diagnosis of MDS. 3. Performance status of 0, 1 or 2 by the ECOG scale, and estimated life expectancy of at least 6 months 4. Adequate organ function 5. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted 6. Able to adhere to the study visit schedule and other protocol requirements 7. Must have recovered from all toxic effects of prior therapy for myelodysplastic syndrome and not received any chemotherapy for a minimum of 4 weeks prior to the first dose of study drug
Exclusion criteria
Exclusion criteria: 1. Known allergy or hypersensitivity to azacitidine or mannitol or any other component of the formulation 2. Sex and Reproductive Status o Women of child bearing potential (WOCBP) who are unwilling or unable to use an physician-approved contraceptive method with low failure rate (less than 1 percentage per year when used consistently and correctly) to avoid pregnancy for the entire study period and for up to 3 months after the last dose of azacitidine o Women who are pregnant and breastfeeding o Women with a positive pregnancy test on screening or within 72 hours prior to first azacitidine administration o Male subjects with a female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study and avoid fathering a child during the course of the study and for 3 months following the last dose of azacitidine 3. Relapsed or Refractory OR Hypoplastic OR Secondary myelodysplastic syndromes (MDS) 4. Prior history of acute myeloid leukemia (AML) 5. Patients must not have undergone prior allogeneic stem cell or bone marrow transplantation at any time 6. Patients must not have received lenalidomide, vorinostat or other histone deacetylase (HDAC) inhibitor, or hypomethylating agents (azacitidine, decitabine) as treatment previously 7. Treatment with erythropoietin or myeloid growth factors (granulocyte colonystimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor [GM-CSF]) during the 21 days prior to Day 1 of Cycle 1 8. Treatment with androgenic hormones during the 14 days prior to Day 1 of Cycle 1 9. Patients with active malignancy of other type than required for this study are not eligible with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast 10. Diagnosis of metastatic disease and malignant hepatic tumors 11. Must not have associated autoimmune hemolytic anemia or immune thrombocytopenia and inaspirable bone marrow 12. Known positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibody (Anti-HCV Ab) or human immunodeficiency virus (HIV) 13. Treatment with any other investigational drugs during prior 30 days or 5 half-lives prior to first study treatment, whichever is longer 14. Documented serum folate deficiency or vitamin B12 deficiency within the last 28- day before enrolment 15. Must not have a mental illness or any other condition (eg, uncontrolled cardiac or pulmonary disease, diabetes), that could prevent full cooperation with the study requirements 16. Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study OR would prevent that person from giving informed consent OR confounds the ability to interpret data from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nature, frequency and severity of adverse events (AEs) and their relationship to treatmentTimepoint: At completion of 6 cycle of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?· Overall response rate (patients with complete remission (CR), partial remission (PR) and haematological improvement (HI)) by modified IWG 2006 response criteria ï?· Complete remission and partial remission rate in response to Azacitidine treatment by modified IWG 2006 response criteriaTimepoint: During entire duration of study | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed