PM534 Administered Intravenously to Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. Concomitant diseases/conditions:
• •1. Increased cardiac risk:
• •* History of long QT syndrome.
• •* Corrected QT interval (QTcF, Fridericia correction) ≥450 msec on screening electrocardiogram (ECG).
• •* History of or current ischemic heart disease, including myocardial infarction, stable/unstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction or symptomatic arrhythmia.
• •* History of heart failure or left ventricular dysfunction (left ventricular ejection fraction \[LVEF\] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).
• •* Clinically significant ECG abnormalities, including any of the following: right bundle branch block with left anterior hemiblock, second (Mobitz II) or third degree atrioventricular block and findings suggestive of ischemic heart disease.
• •* Symptomatic arrhythmia.
• •* Use of a cardiac pacemaker.
• •* History of or current peripheral vascular disease or cerebrovascular disease.
• •2. Presence of:
• •* Any grade of peripheral neuropathy (any etiology) at study entry.
• •* Prior history of grade ≥ 2 peripheral neuropathy due to any chemotherapeutic or investigational agent.
• •* Clinical or radiological signs of subocclusion/bowel obstruction.
• •3. Active infection requiring systemic treatment.
• •4. Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B.
• •5. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study
• •2. Symptomatic, steroid-requiring, central nervous system (CNS) disease.
• •3. Patients with carcinomatous meningitis.
• •4. Prior bone marrow or stem cell transplantation.
• •5. Current treatment with colchicine.
• •6. Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM534
• •7. Known hypersensitivity to any of the components of the drug product.
• •8. Limitation of the patient's ability to comply with the treatment or to follow the protocol procedures.
• •9. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception
• •10. Patients with pulmonary lymphangitis.
• •11. Use of medications with known risk of inducing torsades de pointes (TdP) within five half-lives prior to the first infusion of PM534