ENVELOP a multi-part clinical research study for adults with different types of
blood and bone marrow conditions called Myeloﬁbrosis (MF), Essential
thrombocythemia (ET), Polycythemia vera (PV) or Chronic myelomonocytic
leukemia (CMML). This information will be focusing on two parts of the study,
Parts 3 and 4. You can learn more about Parts 3 and 4 of the study by
reviewing the information below.
Part 3: The main purpose of Part 3 is to understand the effects of the
investigational medicine (navitoclax) on the heart (speciﬁcally
Part 4: The main purpose of Part 4 of is to understand the effects of the
investigational drug (navitoclax) on the metabolism (how the body changes
food into energy) and pharmacokinetics (how much of the investigational drug
is absorbed into the blood and how the body handles the investigational drug).
In this study, navitoclax will be administered either given alone (Part 3) or in
combination with the anti-inﬂammatory pain reliever drug Celecoxib
(Celebrex) (Part 4) which will be given only on Days 1 and 7. The study is for
individuals requiring new treatment when previous treatment did not work,
could not be tolerated or the individual declined to receive standard
Part 3 and Part 4 (Participants in US and Europe):
- Part 3 Only: At screening or baseline (pre-dose on Day 1), participant has QT interval corrected for heart rate (QTc) interval by Fridericia’s correction (QTcF) <=470 msec.
- Participants with a documented diagnosis of primary or secondary MF, ET, PV or chronic myelomonocytic leukemia (CMML) as defined by the WHO classification.
- Participants must be requiring treatment and have failed or are intolerant to at least one prior therapy or who refuse standard therapy.
- ECOG performance status <= 2.
- Must have adequate bone marrow, kidney, liver and hematology blood values as detailed in the study protocol