A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03222609 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AbbVie |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
ABBVIE INC. |
Principal Investigator Affiliation | AbbVie |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Belgium, Bulgaria, Canada, Croatia, France, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Puerto Rico, Russian Federation, Serbia, Spain, Taiwan, Turkey, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Myelofibrosis (MF) |
Arms
Experimental: Navitoclax + ruxolitinib
Participants will be administered navitoclax once daily (QD) at various doses and a dose greater than or equal to 10 mg of ruxolitinib twice daily (BID).
Experimental: Navitoclax
Participants will be administered various doses of navitoclax once daily (QD)
Interventions
Drug: - Ruxolitinib
Tablet; Oral
Drug: - Navitoclax
Tablet; Oral
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
UAB Comprehensive Cancer Cente /ID# 165464
Birmingham, Alabama, 35217
Status
Recruiting
Address
City of Hope /ID# 221395
Duarte, California, 91010
Status
Recruiting
Address
St. Joseph Heritage Healthcare /ID# 230935
Fullerton, California, 92835
Status
Completed
Address
Moore UC San Diego Cancer Center /ID# 164084
La Jolla, California, 92093
Status
Not yet recruiting
Address
Long Beach Memorial Medical Ct /ID# 230148
Long Beach, California, 90806-1701
Status
Recruiting
Address
Universtiy of Southern California /ID# 164095
Los Angeles, California, 90033
Status
Recruiting
Address
Ventura Oncology /ID# 230940
Oxnard, California, 93030-3790
Status
Recruiting
Address
St Joseph Heritage Healthcare /ID# 230936
Santa Rosa, California, 95403
Status
Recruiting
Address
Icri /Id# 222546
Whittier, California, 90603
Status
Recruiting
Address
Colorado Blood Cancer Institute /ID# 224250
Denver, Colorado, 80218
Status
Recruiting
Address
Eastern Connecticut Hematology and Oncology Associates /ID# 230918
Norwich, Connecticut, 06360-2700
Status
Recruiting
Address
Holy Cross Hospital /ID# 230922
Fort Lauderdale, Florida, 33308
Status
Recruiting
Address
Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548
Jacksonville, Florida, 32207-8432
Status
Recruiting
Address
Mayo Clinic /ID# 164201
Jacksonville, Florida, 32224
Status
Recruiting
Address
Cancer Specialists of North Florida /ID# 230917
Jacksonville, Florida, 32256
Status
Recruiting
Address
Ocala Oncology Florida Cancer Affiliates /ID# 230927
Ocala, Florida, 34474-4445
Status
Recruiting
Address
Moffitt Cancer Center /ID# 164082
Tampa, Florida, 33612-9416
Status
Recruiting
Address
University Cancer & Blood Center /ID# 230939
Athens, Georgia, 30607
Status
Recruiting
Address
University of Chicago Medicine /ID# 164115
Chicago, Illinois, 60637-1426
Status
Recruiting
Address
Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536
Normal, Illinois, 61761
Status
Not yet recruiting
Address
Carle Cancer Institute /ID# 230571
Urbana, Illinois, 61801-1645
Status
Recruiting
Address
Fort Wayne Medical Oncology /ID# 230919
Fort Wayne, Indiana, 46804
Status
Recruiting
Address
Indiana Blood & Marrow Transpl /ID# 165075
Indianapolis, Indiana, 46237
Status
Recruiting
Address
Community Health Network /ID# 230915
Indianapolis, Indiana, 46250-2042
Status
Recruiting
Address
Memorial Hospital of South Bend /ID# 230912
South Bend, Indiana, 46601-1033
Status
Recruiting
Address
Pontchartrain Cancer Center /ID# 230932
Covington, Louisiana, 70433-7512
Status
Recruiting
Address
The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA /ID# 231299
Bethesda, Maryland, 20817
Status
Recruiting
Address
Frederick Health /ID# 230920
Frederick, Maryland, 21702-4920
Status
Recruiting
Address
Dana-Farber Cancer Institute /ID# 162675
Boston, Massachusetts, 02215
Status
Recruiting
Address
Southcoast Health Cancer Center /ID# 230934
Fairhaven, Massachusetts, 02719-5208
Status
Recruiting
Address
University of Massachusetts Wo /ID# 222547
Worcester, Massachusetts, 01655
Status
Recruiting
Address
Henry Ford Hospital /ID# 162682
Detroit, Michigan, 48202
Status
Recruiting
Address
Ascension Providence Southfield Cancer Center /ID# 223876
Southfield, Michigan, 48075-3707
Status
Recruiting
Address
Central Care Cancer Center /ID# 230913
Bolivar, Missouri, 65613
Status
Recruiting
Address
Capital Region Medical Center /ID# 232627
Jefferson City, Missouri, 65102
Status
Recruiting
Address
MidAmerica Division, Inc. /ID# 222058
Kansas City, Missouri, 64132
Status
Recruiting
Address
Heartland Regional Medical Center, St.Joseph Mosaic Life Care Cancer Care / ID# 230924
Saint Joseph, Missouri, 64507
Status
Recruiting
Address
Comprehensive Cancer Centers of Nevada /ID# 230916
Las Vegas, Nevada, 89169-3321
Status
Recruiting
Address
New Jersey Cancer Care & Blood Disorders /ID# 230925
Belleville, New Jersey, 07109-3550
Status
Recruiting
Address
Summit Medical Group /ID# 230937
Florham Park, New Jersey, 07932-1049
Status
Recruiting
Address
Weill Cornell Medical College /ID# 162679
New York, New York, 10065
Status
Recruiting
Address
Southeastern Medical Oncology Center /ID# 230954
Goldsboro, North Carolina, 27534
Status
Recruiting
Address
Univ Hosp Cleveland: Seidman Cancer Center /ID# 230938
Cleveland, Ohio, 44106
Status
Recruiting
Address
The Ohio State University /ID# 217402
Columbus, Ohio, 43210-1280
Status
Recruiting
Address
OhioHealth /ID# 230928
Columbus, Ohio, 43214
Status
Recruiting
Address
Oklahoma Cancer Specialists /ID# 230929
Tulsa, Oklahoma, 74146
Status
Recruiting
Address
Bend Memorial Clinic /ID# 224184
Bend, Oregon, 97701
Status
Recruiting
Address
Oregon Oncology Specialists /ID# 230931
Salem, Oregon, 97301-3975
Status
Recruiting
Address
Gettysburg Cancer Center /ID# 230921
Gettysburg, Pennsylvania, 17325
Status
Recruiting
Address
West Penn Hospital /ID# 222618
Pittsburgh, Pennsylvania, 15224-1722
Status
Recruiting
Address
Medical University of South Carolina /ID# 222597
Charleston, South Carolina, 29425
Status
Not yet recruiting
Address
St Francis Cancer Center /ID# 230254
Greenville, South Carolina, 29607-5253
Status
Recruiting
Address
Sanford Cancer Center /ID# 230933
Sioux Falls, South Dakota, 57104-4663
Status
Recruiting
Address
Avera Cancer Institute /ID# 222364
Sioux Falls, South Dakota, 57105
Status
Not yet recruiting
Address
Prairie Lakes Healthcare System /ID# 224358
Watertown, South Dakota, 57201
Status
Completed
Address
Tennessee Oncology-Nashville Centennial /ID# 221410
Nashville, Tennessee, 37203-1632
Status
Recruiting
Address
Texas Oncology - West Texas /ID# 224784
Abilene, Texas, 79606
Status
Recruiting
Address
Mary Crowley Cancer Research /ID# 230923
Dallas, Texas, 75230
Status
Recruiting
Address
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159
Dallas, Texas, 75246-2003
Status
Recruiting
Address
Oncology Consultants /ID# 230930
Houston, Texas, 77030-3306
Status
Recruiting
Address
MD Anderson Cancer Center at Texas Medical Center /ID# 162683
Houston, Texas, 77030-4000
Status
Completed
Address
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094
San Antonio, Texas, 78229
Status
Recruiting
Address
Community Cancer Trials of Utah /ID# 230914
Ogden, Utah, 84405-7194
Status
Recruiting
Address
Utah Cancer Specialists Salt Lake Clinic /ID# 222806
Salt Lake City, Utah, 84106
Status
Recruiting
Address
University of Utah /ID# 164116
Salt Lake City, Utah, 84112-5500
Status
Recruiting
Address
Hematology Oncology Associates of Fredericksburg /ID# 231372
Fredericksburg, Virginia, 22408-1949
Status
Recruiting
Address
Northwest Medical Specialties /ID# 230926
Tacoma, Washington, 98405
International Sites
Status
Recruiting
Address
The Kinghorn Cancer Centre /ID# 214657
Darlinghurst, New South Wales, 2010
Status
Recruiting
Address
Barwon Health /ID# 222430
Geelong, Victoria, 3220
Status
Recruiting
Address
Peter MacCallum Cancer Ctr /ID# 218352
Melbourne, Victoria, 3000
Status
Recruiting
Address
Alfred Health /ID# 215545
Melbourne, Victoria, 3004
Status
Recruiting
Address
Fiona Stanley Hospital /ID# 216809
Murdoch, Western Australia, 6150
Status
Not yet recruiting
Address
AZ Klina /ID# 230592
Brasschaat, , 2930
Status
Not yet recruiting
Address
UMHAT Sveti Ivan Rilski /ID# 231163
Sofia, , 1431
Status
Not yet recruiting
Address
UMHAT Sveta Marina /ID# 231411
Varna, , 9010
Status
Recruiting
Address
University of Alberta Hospital - Division of Hematology /ID# 217698
Edmonton, Alberta, T6G 2B7
Status
Recruiting
Address
Princess Margaret Cancer Centre /ID# 214483
Toronto, Ontario, M5G 2M9
Status
Not yet recruiting
Address
Jewish General Hospital /ID# 217586
Montreal, Quebec, H3T 1E2
Status
Recruiting
Address
McGill University Health Center Research Institute /ID# 223976
Montreal, Quebec, H4A 3J1
Status
Recruiting
Address
Klinicka bolnica Dubrava Zagreb /ID# 230504
Zagreb, Grad Zagreb, 10000
Status
Not yet recruiting
Address
Klinicka bolnica Merkur /ID# 230599
Zagreb, Grad Zagreb, 10000
Status
Not yet recruiting
Address
Klinicki bolnicki centar Zagreb /ID# 230602
Zagreb, Grad Zagreb, 10000
Status
Recruiting
Address
Klinicki bolnicki centar Split /ID# 230601
Split, , 21000
Status
Not yet recruiting
Address
Centre Hospitalier de CHAMBERY /ID# 230889
Chambery, , 73000
Status
Not yet recruiting
Address
CHU de Nimes /ID# 230888
Nimes, , 30029
Status
Not yet recruiting
Address
AP-HP - Hopital Necker /ID# 230900
Paris, , 75015
Status
Not yet recruiting
Address
Hopital Saint Louis /ID# 230887
Paris, , 75475
Status
Not yet recruiting
Address
General Hospital of Athens Laiko /ID# 230394
Athens, Attiki, 11527
Status
Recruiting
Address
University General Hospital Attikon /ID# 230395
Athens, Attiki, 12462
Status
Not yet recruiting
Address
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230393
Athens, , 10676
Status
Not yet recruiting
Address
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet /ID# 230306
Budapest IX, Budapest, 1097
Status
Not yet recruiting
Address
Semmelweis Egyetem /ID# 230518
Budapest, , 1085
Status
Recruiting
Address
Szabolcs - Szatmar - Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras /ID# 230585
Nyiregyhaza, , 4400
Status
Recruiting
Address
Hadassah Medical Center-Hebrew University /ID# 230310
Jerusalem, Yerushalayim, 9112001
Status
Recruiting
Address
Assuta Ashdod Medical Center /ID# 230396
Ashdod, , 7747629
Status
Not yet recruiting
Address
Galilee Medical Center /ID# 230397
Nahariya, , 2210001
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center /ID# 230311
Tel Aviv, , 6423906
Status
Not yet recruiting
Address
A.O.U. Policlinico S.Orsola-Malpighi /ID# 230012
Bologna, Emilia-Romagna, 40138
Status
Recruiting
Address
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553
Rome, Lazio, 00168
Status
Recruiting
Address
ASST Papa Giovanni XXIII /ID# 214900
Bergamo, , 24127
Status
Recruiting
Address
ASST Spedali civili di Brescia /ID# 230420
Brescia, , 25123
Status
Recruiting
Address
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214549
Catania, , 95123
Status
Recruiting
Address
Azienda Ospedaliero Universitaria Careggi /ID# 214555
Florence, , 50134
Status
Recruiting
Address
Grande Ospedale Metropolitano-Bianchi-Melacrino /ID# 230011
Reggio Calabria, , 89124
Status
Recruiting
Address
ASST Sette Laghi /ID# 214551
Varese, , 21100
Status
Recruiting
Address
Fujita Health University Hospital /ID# 221539
Toyoake-shi, Aichi, 470-1192
Status
Recruiting
Address
Aomori Prefectural Central Hospital /ID# 221773
Aomori-shi, Aomori, 030-8553
Status
Recruiting
Address
Kyushu University Hospital /ID# 222691
Fukuoka-shi, Fukuoka, 812-8582
Status
Recruiting
Address
Keiyukai Daini Hospital /ID# 222693
Sapporo-shi, Hokkaido, 730-0035
Status
Recruiting
Address
Kansai Medical University Hospital /ID# 222690
Hirakata-shi, Osaka, 573-1191
Status
Recruiting
Address
Kindai University Hospital /ID# 222689
Osakasayama-shi, Osaka, 589-8511
Status
Recruiting
Address
Dokkyo Medical University Saitama Medical Center /ID# 222332
Koshigaya-shi, Saitama, 343-8555
Status
Recruiting
Address
Juntendo University Hospital /ID# 221484
Bunkyo-ku, Tokyo, 113-8431
Status
Recruiting
Address
Nippon Medical School Hospital /ID# 222692
Bunkyo-ku, Tokyo, 113-8603
Status
Recruiting
Address
University of Yamanashi Hospital /ID# 221700
Chuo-shi, Yamanashi, 409-3821
Status
Recruiting
Address
Seoul National University Hospital /ID# 230380
Seoul, , 03080
Status
Recruiting
Address
Samsung Medical Center /ID# 230381
Seoul, , 06351
Status
Not yet recruiting
Address
ARS-MEDICAL Sp. z o.o. /ID# 230809
Pila, Wielkopolskie, 64-920
Status
Recruiting
Address
VA Caribbean Healthcare System /ID# 222416
San Juan, , 00921-3201
Status
Recruiting
Address
Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544
San Juan, , 00927
Status
Not yet recruiting
Address
City Clinical Hospital named after S.P. Botkin /ID# 230508
Moscow, , 125284
Status
Not yet recruiting
Address
Leningrad Regional Clinical Hospital /ID# 230507
Saint Petersburg, , 194291
Status
Not yet recruiting
Address
Heart Blood and Endocrinology Federal Center n.a. V.A. Almazov /ID# 230506
Saint Petersburg, , 197341
Status
Not yet recruiting
Address
University Clinical Center Serbia /ID# 230629
Belgrade, Beograd, 11000
Status
Not yet recruiting
Address
Clin Hosp Ctr Bezanijska Kosa /ID# 230681
Belgrade, Beograd, 11080
Status
Not yet recruiting
Address
University Clinical Center Kragujevac /ID# 230550
Kragujevac, Sumadijski Okrug, 34000
Status
Not yet recruiting
Address
Clinical Center Vojvodina /ID# 230525
Novi Sad, Vojvodina, 21000
Status
Not yet recruiting
Address
Hospital Universitario Central de Asturias /ID# 230884
Oviedo, Asturias, 33011
Status
Recruiting
Address
Hospital Universitario Germans Trias i Pujol /ID# 214704
Badalona, Barcelona, 08916
Status
Not yet recruiting
Address
Hospital Regional de Malaga /ID# 230858
Málaga, Malaga, 29010
Status
Not yet recruiting
Address
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718
Pamplona, Navarra, Comunidad, 31008
Status
Recruiting
Address
Hospital Universitario Vall d'Hebron /ID# 222415
Barcelona, , 08035
Status
Not yet recruiting
Address
Hospital Clinic de Barcelona /ID# 231538
Barcelona, , 08036
Status
Recruiting
Address
Hospital General Universitario Gregorio Maranon /ID# 214676
Madrid, , 28007
Status
Not yet recruiting
Address
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719
Madrid, , 28027
Status
Recruiting
Address
Hospital Universitario 12 de Octubre /ID# 214710
Madrid, , 28041
Status
Recruiting
Address
Hospital Universitario Virgen de la Victoria /ID# 214709
Malaga, , 29010
Status
Recruiting
Address
Kaohsiung Chang Gung Memorial Hospital /ID# 230371
Kaohsiung, , 833
Status
Not yet recruiting
Address
National Cheng Kung University Hospital /ID# 230372
Tainan City, , 70403
Status
Not yet recruiting
Address
Ankara Universitesi Fakultesi /ID# 230317
Ankara, , 06620
Status
Not yet recruiting
Address
Adnan Menderes University /ID# 230777
Aydin, , 09100
Status
Not yet recruiting
Address
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 230318
Istanbul, , 34098
Status
Not yet recruiting
Address
Dokuz Eylul University Medical Faculty /ID# 231321
Izmir, , 35340
Status
Not yet recruiting
Address
Ondokuz mayis University Facul /ID# 230314
Samsun, , 55200
Status
Recruiting
Address
Guy's and St Thomas' NHS Foundation Trust /ID# 164110
London, London, City Of, SE1 9RT
Status
Recruiting
Address
Oxford Univ Hosp NHS Trust /ID# 214503
Oxford, Oxfordshire, OX3 7LE
Status
Recruiting
Address
Belfast Health and Social Care Trust /ID# 216991
Belfast, , BT9 7AB
Status
Recruiting
Address
The Christie Hospital /ID# 164111
Manchester, , M20 4BX
Status
Recruiting
Address
Aneurin Bevan University Health Board /ID# 230332
Newport, , NP18 3XQ