M19-753

Inclusiecriteria: U mag meedoen als

Part 1 and Part 2 of the study are not being conducted within the EEA.

Part 3
• Subjects ≥ 18 years old
• At screening or baseline (pre-dose on Day 1), subject has QTc interval by Fridericia's correction (QTcF) ≤ 470 msec.
• Subjects with a documented diagnosis of primary or secondary MF, ET, PV or chronic myelomonocytic leukemia (CMML) as defined by the WHO classification.
• Subject must be requiring treatment and have failed or are intolerant to at least one prior therapy or who refuse standard therapy.
• Subject must have an ECOG performance status ≤ 2.
• Subject must meet laboratory parameters for bone marrow reserves, platelet count, neutrophil count, renal function, hepatic function and enzymes, AST and ALT, Billirubin, coagulation and serum potassium.

Part 4
• Subjects ≥ 18 years old
• Subjects with a documented diagnosis of primary or secondary MF, ET, PV or chronic myelomonocytic leukemia (CMML) as defined by the WHO classification.
• Subject must be requiring treatment and have failed or are intolerant to at least one prior therapy or who refuse standard therapy.
• Subject must have an ECOG performance status ≤ 2.
• Subject must meet laboratory parameters for bone marrow reserves, platelet count, neutrophil count, renal function, hepatic function and enzymes, AST and ALT, Billirubin, coagulation and serum potassium.

Exclusiecriteria: U mag niet meedoen als

Part 1 and Part 2 of the study are not being conducted within the EEA.

Part 3
• Subject must not show leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy).
• Subject must not be currently on medications that interfere with coagulation (including warfarin) or platelet function except for low-dose aspirin (up to 100 mg) and LMWH.
• Subject must not have had prior therapy with a BH3 mimetic compound.
• Subject must not have received strong or moderate CYP3A inhibitors within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of navitoclax.
• Subject must not have received strong CYP3A inducers within 10 days prior to the first dose of navitoclax.

Part 4
• Subject must not show leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy).
• Subject must not be currently on medications that interfere with coagulation (including warfarin) or platelet function except for low-dose aspirin (up to 100 mg) and LMWH.
• Subject must not have had prior therapy with a BH3 mimetic compound.
• Subject must not have received strong or moderate CYP3A inhibitors or CYP2C9 within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study drugs.
• Subject must not have received strong or moderate CYP2C9 inhibitors within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of study drugs.
• Subject must not have received strong CYP3A or CYP2C9 inducers within 10 days prior to the first dose of study drugs.

• Cliniques Universitaires Saint-Luc