Myeloproliferative Neoplasms Clinical Trial
A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis
Summary
This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.
Eligibility Criteria
Inclusion Criteria:
Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.
Participant must be ineligible due to age, comorbidities, or unfit for unrelated or unmatched donor transplantation or unwilling to undergo stem cell transplantation at time of study entry.
Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2.
Prior treatment must meet at least one of the following criteria:
Prior or current treatment with ruxolitinib and no prior treatment with a Bromodomain and Extra-Terminal motif (BET) proteins inhibitor or another Janus Kinase 2 (JAK-2) inhibitor, and meet all of the following criteria:
Ruxolitinib treatment must meet at least one of the following criteria:
Ruxolitinib treatment for >=24 weeks with lack of efficacy defined as a lack of spleen response (refractory) or a loss of spleen or symptom response (relapsed)
Ruxolitinib treatment for <24 weeks with documented disease progression on spleen measurements while on ruxolitinib as defined in the protocol:
Ruxolitinib treatment for >=28 days with intolerance defined as new red blood cell transfusion requirement (at least 2 units/month for 2 months) while receiving a total daily ruxolitinib dose of >=30 mg but unable to reduce dose further due to lack of efficacy.
If receiving ruxolitinib at the time of screening, must currently be on a stable dose >=10 mg twice daily of ruxolitinib for >=4 weeks prior to the 1st dose of navitoclax.
Participant has at least 2 symptoms each with a score >=3 or a total score of >=12, as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days during screening prior to study drug dosing; OR
Prior treatment with a JAK-2 inhibitor and meet one of the following criteria:
Prior treatment with a JAK-2 inhibitor for at least 12 weeks
Prior treatment with a JAK-2 inhibitor for >=28 days complicated by either development of red blood cell transfusion requirement (at least 2 units/month for 2 months) OR Grade >= 3 adverse events of thrombocytopenia, anemia, hematoma and/or hemorrhage while on JAK-2 inhibitor treatment; OR
No prior treatment with a JAK-2 or BET inhibitor:
Participant has at least 2 symptoms each with a score >=3 or a total score of >= 12, as measured by the MFSAF v4.0 on at least 4 out of 7 days during screening prior to study drug dosing.
Participant has splenomegaly as defined in the protocol.
Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.
Exclusion Criteria:
Splenic irradiation within 6 months prior to screening, or prior splenectomy.
Leukemic transformation (> 10% blasts in peripheral blood or bone marrow aspirate/biopsy).
Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function within 3 days prior to the first dose of study drug or during the study treatment period with the exception of low dose aspirin (up to 100 mg/day) and low-molecular-weight heparin.
Prior therapy with a BH3 mimetic compound or stem cell transplantation.
Participant has received strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin) or moderate CYP3A inhibitors (e.g., fluconazole) within 14 days prior to the administration of the first dose of study drug.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 143 Locations for this study
Birmingham Alabama, 35217, United States
Duarte California, 91010, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Long Beach California, 90806, United States
Los Angeles California, 90033, United States
Oxnard California, 93030, United States
Santa Rosa California, 95403, United States
Whittier California, 90603, United States
Denver Colorado, 80218, United States
Norwich Connecticut, 06360, United States
Fort Lauderdale Florida, 33308, United States
Jacksonville Florida, 32207, United States
Jacksonville Florida, 32224, United States
Jacksonville Florida, 32256, United States
Ocala Florida, 34474, United States
Tampa Florida, 33612, United States
Athens Georgia, 30607, United States
Chicago Illinois, 60637, United States
Normal Illinois, 61761, United States
Urbana Illinois, 61801, United States
Fort Wayne Indiana, 46804, United States
Indianapolis Indiana, 46237, United States
Indianapolis Indiana, 46250, United States
South Bend Indiana, 46601, United States
Covington Louisiana, 70433, United States
Bethesda Maryland, 20817, United States
Frederick Maryland, 21702, United States
Boston Massachusetts, 02215, United States
Fairhaven Massachusetts, 02719, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48202, United States
Southfield Michigan, 48075, United States
Bolivar Missouri, 65613, United States
Jefferson City Missouri, 65102, United States
Kansas City Missouri, 64132, United States
Saint Joseph Missouri, 64507, United States
Las Vegas Nevada, 89169, United States
Belleville New Jersey, 07109, United States
Florham Park New Jersey, 07932, United States
New York New York, 10065, United States
Goldsboro North Carolina, 27534, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Tulsa Oklahoma, 74146, United States
Bend Oregon, 97701, United States
Salem Oregon, 97301, United States
Gettysburg Pennsylvania, 17325, United States
Pittsburgh Pennsylvania, 15224, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29607, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57105, United States
Watertown South Dakota, 57201, United States
Nashville Tennessee, 37203, United States
Abilene Texas, 79606, United States
Dallas Texas, 75230, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Ogden Utah, 84405, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Fredericksburg Virginia, 22408, United States
Tacoma Washington, 98405, United States
Darlinghurst New South Wales, 2010, Australia
Geelong Victoria, 3220, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Murdoch Western Australia, 6150, Australia
Brasschaat , 2930, Belgium
Sofia , 1431, Bulgaria
Varna , 9010, Bulgaria
Edmonton Alberta, T6G 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A 3, Canada
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Split , 21000, Croatia
Chambery , 73000, France
Nimes , 30029, France
Paris , 75015, France
Paris , 75475, France
Athens Attiki, 11527, Greece
Athens Attiki, 12462, Greece
Athens , 10676, Greece
Budapest IX Budapest, 1097, Hungary
Budapest , 1085, Hungary
Nyiregyhaza , 4400, Hungary
Jerusalem Yerushalayim, 91120, Israel
Ashdod , 77476, Israel
Nahariya , 22100, Israel
Tel Aviv , 64239, Israel
Bologna Emilia-Romagna, 40138, Italy
Rome Lazio, 00168, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Catania , 95123, Italy
Florence , 50134, Italy
Reggio Calabria , 89124, Italy
Varese , 21100, Italy
Toyoake-shi Aichi, 470-1, Japan
Aomori-shi Aomori, 030-8, Japan
Fukuoka-shi Fukuoka, 812-8, Japan
Sapporo-shi Hokkaido, 730-0, Japan
Hirakata-shi Osaka, 573-1, Japan
Osakasayama-shi Osaka, 589-8, Japan
Koshigaya-shi Saitama, 343-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Chuo-shi Yamanashi, 409-3, Japan
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Pila Wielkopolskie, 64-92, Poland
San Juan , 00921, Puerto Rico
San Juan , 00927, Puerto Rico
Moscow , 12528, Russian Federation
Saint Petersburg , 19429, Russian Federation
Saint Petersburg , 19734, Russian Federation
Belgrade Beograd, 11000, Serbia
Belgrade Beograd, 11080, Serbia
Kragujevac Sumadijski Okrug, 34000, Serbia
Novi Sad Vojvodina, 21000, Serbia
Oviedo Asturias, 33011, Spain
Badalona Barcelona, 08916, Spain
Málaga Malaga, 29010, Spain
Pamplona Navarra, Comunidad, 31008, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Kaohsiung , 833, Taiwan
Tainan City , 70403, Taiwan
Ankara , 06620, Turkey
Aydin , 09100, Turkey
Istanbul , 34098, Turkey
Izmir , 35340, Turkey
Samsun , 55200, Turkey
London London, City Of, SE1 9, United Kingdom
Oxford Oxfordshire, OX3 7, United Kingdom
Belfast , BT9 7, United Kingdom
Manchester , M20 4, United Kingdom
Newport , NP18 , United Kingdom
How clear is this clinincal trial information?