Spots Global Cancer Trial Database for Safety and Tolerability Study of Oral ABBV-744 Tablet Alone or in Combination With Oral Ruxolitinib Tablet or Oral Navitoclax Tablet in Adult Participants With Myelofibrosis
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Safety and Tolerability Study of Oral ABBV-744 Tablet Alone or in Combination With Oral Ruxolitinib Tablet or Oral Navitoclax Tablet in Adult Participants With Myelofibrosis
Official Title: A Phase 1b Study Of ABBV-744 Alone Or In Combination With Ruxolitinib Or Navitoclax In Subjects With Myelofibrosis
Study ID: NCT04454658
Conditions
Study Description
Brief Summary: Myelofibrosis (MF) is a bone marrow illness that affects blood-forming tissues in the body. MF disturbs the body's normal production of blood cells, causing extensive scarring in the bone marrow. This leads to severe anemia, weakness, fatigue, and an enlarged spleen. The purpose of this study is to see how safe and tolerable ABBV-744 is, when given alone, and in combination with ruxolitinib or navitoclax, for adult participants with MF. ABBV-744 is an investigational drug being developed for the treatment of MF. The study has 4 segments - A, B, C, and D. In Segment A, the safe dosing regimen of ABBV-744 is identified and then, given alone as monotherapy. In Segment B, C, and D, combination therapies of ABBV-744 with either ruxolitinib or navitoclax are given. Adult participants with a diagnosis of MF will be enrolled. Around 130 participants will be enrolled in 60 sites worldwide. In Segment A, participants will receive different doses and schedules of oral ABBV-744 tablet to identify safe dosing regimen. Additional participants will be enrolled at the identified monotherapy dosign regimen. In Segment B, participants will receive oral ruxolitinib and ABBV-744 will be given as "add-on" therapy. In Segment C, participants will receive ABBV-744 and oral navitoclax. In Segment D, participants will receive ABBV-744 and ruxolitinib. Participants will receive treatment until disease progression or the participants are not able to tolerate the study drugs. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Davis Comprehensive Cancer Center /ID# 221790, Sacramento, California, United States
Dartmouth-Hitchcock Medical Center /ID# 224623, Lebanon, New Hampshire, United States
Roswell Park Comprehensive Cancer Center /ID# 222557, Buffalo, New York, United States
The Mount Sinai Hospital /ID# 221549, New York, New York, United States
Weill Cornell Medical College /ID# 227069, New York, New York, United States
Gabrail Cancer Center Research /ID# 222802, Canton, Ohio, United States
University of Oklahoma, Stephenson Cancer Center /ID# 224095, Oklahoma City, Oklahoma, United States
Oregon Health and Science Univ /ID# 221801, Portland, Oregon, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 240004, Dallas, Texas, United States
VA Puget Sound Health Care System /ID# 224208, Seattle, Washington, United States
Hospital Universitario Austral /ID# 228909, Pilar, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires /ID# 226945, Ciudad Autonoma Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina
Townsville University Hospital /ID# 225859, Douglas, Queensland, Australia
Royal Hobart Hospital /ID# 241677, Hobart, Tasmania, Australia
Royal Perth Hospital /ID# 241678, Perth, Western Australia, Australia
Hospital das Clinicas da Universidade Federal de Goiás /ID# 226636, Goiania, Goias, Brazil
Hospital de Clinicas de Porto Alegre /ID# 226635, Porto Alegre, Rio Grande Do Sul, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 226640, São Paulo, Sao Paulo, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 226637, Rio de Janeiro, , Brazil
Real e Benemérita Associação Portuguesa de Beneficência /ID# 226641, Sao Paulo, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226639, Sao Paulo, , Brazil
SHAT Hematologic Diseases /ID# 226007, Sofia, , Bulgaria
UMHAT Sveta Marina /ID# 226681, Varna, , Bulgaria
Icegclinic /Id# 231086, La Florida, Region Metropolitana De Santiago, Chile
Fundacion Arturo Lopez Perez /ID# 225037, Providencia, Region Metropolitana Santiago, Chile
Sociedad de Investigaciones Médicas Limitada /ID# 224175, Temuco, , Chile
Clinexpert Kft. Fazis I Vizsgalohely /ID# 242249, Gyongyos, Heves, Hungary
Semmelweis Egyetem /ID# 224085, Budapest, , Hungary
The Chaim Sheba Medical Center /ID# 222151, Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 223548, Tel Aviv-Yafo, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 243852, Jerusalem, Yerushalayim, Israel
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244397, Milan, , Italy
Kyushu University Hospital /ID# 228035, Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital /ID# 228038, Sapporo-shi, Hokkaido, Japan
Osaka Metropolitan University Hospital /ID# 225502, Osaka-shi, Osaka, Japan
University of Yamanashi Hospital /ID# 225503, Chuo-shi, Yamanashi, Japan
Inje University Busan Paik Hospital /ID# 233707, Busan, , Korea, Republic of
Hospital Santa Creu i Sant Pau /ID# 238501, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 233279, Madrid, , Spain
Orebro Universitetssjukhuset /ID# 228514, Orebro, Orebro Lan, Sweden
Akademiska Sjukhuset /ID# 228515, Uppsala, Uppsala Lan, Sweden
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 234215, Ankara, , Turkey
Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 234214, Istanbul, , Turkey
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
