Clinical Study of PM01183 in Patients With Acute Leukemia or Relapsed/Refractory Myelodysplastic Syndrome

Exclusion Criteria

• •Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods throughout the treatment period and for six months after discontinuation of treatment.
• •Patients who plan to undergo allogeneic BM transplantation within four weeks.
• •Other relevant diseases or adverse clinical conditions:
• •* History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
• •* Symptomatic or unstable cardiac arrhythmias, and/or prolonged QT-QTc grade ≥ 2.
• •* History of significant neurological or psychiatric disorders that may affect the patient's compliance with the protocol assessments.
• •* Active uncontrolled infection.
• •* Myopathy or any clinical situation that causes significant and persistent elevation of CPK (\> 2.5 x ULN in two different determinations performed one week apart).
• •* Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
• •* Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
• •Hematopoietic allogeneic stem cell transplantation within the last four months and/or active graft versus host disease, or prior autologous transplantation within the last four weeks.
• •Patients known to be human immunodeficiency virus (HIV) positive.
• •Cytotoxic chemotherapy within the last two weeks; radiation therapy within the last two weeks; biologic agents, including hematopoietic growth factors, within the last week; hydroxyurea, imatinib, corticosteroids and arsenic trioxide should be discontinued at least 24 hours prior to first study drug administration.
• •Treatment with any investigational product in the ≤ 5 half-lives period prior to inclusion in the study, or 30 days after therapy (in case of unknown half-life), unless evidence of rapid proliferating disease and upon discussion with the Sponsor.
• •Known hypersensitivity to any of the components of the drug product (DP).