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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

Primary Purpose

Myelofibrosis (MF)

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-744
Navitoclax
Ruxolitinib
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelofibrosis (MF) focused on measuring ABBV-744, Navitoclax, Ruxolitinib, ABT-263, Cancer, Myelofibrosis, MF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Laboratory values indicative of adequate bone marrow, renal, and hepatic function meeting protocol criteria.
  • Completion of the Myelofibrosis System Assessment Form (MFSAF) on at least 4 out of the 7 days prior to Day 1 with at least 2 symptoms with a score >=3 or a total score of >=10.
  • Documented diagnosis of intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocytopenia MF (PET-MF) as defined by the World Health Organization (WHO).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Intermediate - 2, or High-Risk disease as defined by the Dynamic International Prognostic Scoring System (For Segment A only, Intermediate - 1 with palpable splenomegaly >=5 centimeters [cm] below costal margin are also eligible).
  • Splenomegaly defined as spleen palpation measurement >= 5 cm below costal margin or spleen volume >= 450 cubic cms as assessed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan (for Segments A and c, baseline spleen assessment must be obtained > 7 days after discontinuation of most recent Myelofibrosis (MF) therapy. If possible, this assessment should occur within 10 days of Cycle 1 Day 1).

Segment-Specific Prior Therapy Criteria:

  • Segment A:

    • Prior exposure to one or more Janus Kinase inhibitors (JAKi), the most recent of which was discontinued > 28 days prior to Cycle 1, Day 1, and are intolerant, resistant, refractory or lost response to the JAKi.
  • Segment B:

    • Currently receiving ruxolitinib AND
    • Willingness to reduce ruxolitinib dose (if on a higher dose); and on a stable dose for 14 days or longer prior to Cycle 1 Day 1; AND
    • At least one of the following criteria (a, b, or c):

      1. >= 24 weeks duration of current ruxolitinib course, with evidence of disease that is resistant, refractory, or has lost response to ruxolitinib therapy;
      2. < 24 weeks duration of current ruxolitinib course with documented resistance, refractories, or loss of response, as defined by any of the following:

        • Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM), in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
        • >=100% increase in the palpable distance below the LCM, in participants with measurable spleen distance 5 - 10 cm prior to the initiation of ruxolitinib.
        • >=50% increase in the palpable distance below the LCM, in participants with measurable spleen > 10 cm prior to the initiation of ruxolitinib.
        • A spleen volume increase >= 25% (as assessed by MRI or CT) in participants with a spleen volume assessment available prior to the initiation of ruxolitinib.
      3. Prior treatment with ruxolitinib for >= 28 days complicated by any of the following:

        • Development of red blood cell transfusion requirement (at least 2 units/month for 2 months).
        • Grade >= 3 adverse events of neutropenia and/or anemia while on ruxolitinib treatment, with improvement or resolution upon dose reduction.
  • Segment C:

    • Prior exposure to one or more JAKi (the most recent of which was discontinued > 28 days prior to Cycle 1 Day 1), and are intolerant, resistant, refractory or lost response to the JAKi.

Exclusion Criteria:

Segment-Specific Prior Therapy Criteria:

  • Segment A:

    • Prior exposure to one or more Bromodomain and Extra-Terminal (BET) inhibitors.
  • Segment B:

    • Prior exposure to one or more BET inhibitors.
  • Segment C:

    • Prior exposure to one or more BET inhibitors and/or any B-Cell Lymphoma 2 (BCL-2) and/or BCL- XL inhibitor, including navitoclax.
  • Segment D:

    • Prior exposure to JAKi and/or any BET inhibitor.

Sites / Locations

  • University of California, Davis Comprehensive Cancer Center /ID# 221790
  • Dartmouth-Hitchcock Medical Center /ID# 224623
  • Roswell Park Comprehensive Cancer Center /ID# 222557
  • The Mount Sinai Hospital /ID# 221549
  • Weill Cornell Medical College /ID# 227069
  • Gabrail Cancer Center Research /ID# 222802
  • University of Oklahoma, Stephenson Cancer Center /ID# 224095
  • Oregon Health and Science Univ /ID# 221801
  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 240004
  • VA Puget Sound Health Care System /ID# 224208
  • Hospital Universitario Austral /ID# 228909
  • Hospital Italiano de Buenos Aires /ID# 226945
  • Townsville University Hospital /ID# 225859
  • Royal Hobart Hospital /ID# 241677
  • Royal Perth Hospital /ID# 241678
  • Hospital das Clinicas da Universidade Federal de Goiás /ID# 226636
  • Hospital de Clinicas de Porto Alegre /ID# 226635
  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 226640
  • Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 226637
  • Real e Benemérita Associação Portuguesa de Beneficência /ID# 226641
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226639
  • SHAT Hematologic Diseases /ID# 226007
  • UMHAT Sveta Marina /ID# 226681
  • Icegclinic /Id# 231086
  • Fundacion Arturo Lopez Perez /ID# 225037
  • Sociedad de Investigaciones Médicas Limitada /ID# 224175
  • Clinexpert Kft. Fazis I Vizsgalohely /ID# 242249
  • Semmelweis Egyetem /ID# 224085
  • The Chaim Sheba Medical Center /ID# 222151
  • Tel Aviv Sourasky Medical Center /ID# 223548
  • Hadassah Medical Center-Hebrew University /ID# 243852
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244397
  • Kyushu University Hospital /ID# 228035
  • Hokkaido University Hospital /ID# 228038
  • Osaka Metropolitan University Hospital /ID# 225502
  • University of Yamanashi Hospital /ID# 225503
  • Inje University Busan Paik Hospital /ID# 233707
  • Hospital Santa Creu i Sant Pau /ID# 238501
  • Hospital General Universitario Gregorio Maranon /ID# 233279
  • Orebro Universitetssjukhuset /ID# 228514
  • Akademiska Sjukhuset /ID# 228515
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 234215
  • Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 234214

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Segment A: ABBV-744 Dose Identification and Optimization

Segment A: ABBV-744 Monotherapy

Segment B: Ruxolitinib + ABBV-744 "Add on" Therapy

Segment C: ABBV-744 + Navitoclax

Segment D: ABBV-744 + Ruxolitinib

Arm Description

Participants who have been previously treated with Janus Kinase inhibitor(s) (JAKi) and stopped such therapy, will receive different dosing regimens and schedules of ABBV-744 to identify the safe dosing regimen and schedule.

Participants will receive the identified safe dosing regimen of ABBV-744 as monotherapy.

Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and ABBV-744 as "add-on" therapy.

Participants who have previously been exposed to JAKi, and stopped such therapy, will receive ABBV-744 and navitoclax.

Participants who have never received JAKi will receive ABBV-744 and ruxolitinib.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

Secondary Outcome Measures

Percentage Of Participants Who Achieve Spleen Volume Reduction Of 35% Or Greater (SVR35)
Reduction in spleen volume is measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
Maximum Observed Plasma Concentration (Cmax) of ABBV-744
Maximum observed plasma concentration (Cmax) of ABBV-744.
Time To Cmax (Tmax) Of ABBV-744
The amount of time taken to reach Cmax.
Area Under The Concentration Versus Time Curve (AUC) Of ABBV-744
AUC of ABBV-744 will be calculated.
Half-Life (t1/2) Of ABBV-744
Half-life of ABBV-744 will be calculated.
Accumulation Ratio Of ABBV-744
Pharmacokinetic parameters will include accumulation ratio of ABBV-744.
Apparent Clearance (CL/F) Of ABBV-744
CL/F of ABBV-744 will be calculated.
Apparent Volume Of Distribution (Vd/F) Of ABBV-744
Vd/F of ABBV-744 will be calculated.
Percentage Of Participants With >= 50% Reduction In Total Symptom Score (TSS)
TSS is assessed using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. MFSAF v4.0 measures the burden of myelofibrosis-related symptoms. The symptoms are assessed on a 11-point numeric rating scale (NRS) anchored from 0 (absent) to 10 (worst imaginable).
Objective Response Rate (ORR)
ORR is defined as the sum of rates of partial remission (PR) or better.
Maximum Observed Plasma Concentration (Cmax) Of Navitoclax
Maximum Observed Plasma Concentration (Cmax) Of Navitoclax.
Time To Cmax (Tmax) Of Navitoclax
The amount of time taken to reach Cmax.
Area Under The Concentration Versus Time Curve (AUC) Of Navitoclax
AUC of Navitoclax will be calculated.
Maximum Observed Plasma Concentration (Cmax) Of Ruxolitinib
Maximum Observed Plasma Concentration (Cmax) Of Ruxolitinib.
Time To Cmax (Tmax) Of Ruxolitinib
The amount of time taken to reach Cmax.
Area Under The Concentration Versus Time Curve (AUC) Of Ruxolitinib
AUC of Ruxolitinib will be calculated.

Full Information

First Posted
June 30, 2020
Last Updated
September 28, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04454658
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 Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
July 26, 2024 (Anticipated)
Study Completion Date
July 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis (MF)
Keywords
ABBV-744, Navitoclax, Ruxolitinib, ABT-263, Cancer, Myelofibrosis, MF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Segment A: ABBV-744 Dose Identification and Optimization
Arm Type
Experimental
Arm Description
Participants who have been previously treated with Janus Kinase inhibitor(s) (JAKi) and stopped such therapy, will receive different dosing regimens and schedules of ABBV-744 to identify the safe dosing regimen and schedule.
Arm Title
Segment A: ABBV-744 Monotherapy
Arm Type
Experimental
Arm Description
Participants will receive the identified safe dosing regimen of ABBV-744 as monotherapy.
Arm Title
Segment B: Ruxolitinib + ABBV-744 "Add on" Therapy
Arm Type
Experimental
Arm Description
Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and ABBV-744 as "add-on" therapy.
Arm Title
Segment C: ABBV-744 + Navitoclax
Arm Type
Experimental
Arm Description
Participants who have previously been exposed to JAKi, and stopped such therapy, will receive ABBV-744 and navitoclax.
Arm Title
Segment D: ABBV-744 + Ruxolitinib
Arm Type
Experimental
Arm Description
Participants who have never received JAKi will receive ABBV-744 and ruxolitinib.
Intervention Type
Drug
Intervention Name(s)
ABBV-744
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Navitoclax
Other Intervention Name(s)
ABT-263
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Intervention Description
Tablet; Oral
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Time Frame
Up to Approximately 1 year from start of study
Secondary Outcome Measure Information:
Title
Percentage Of Participants Who Achieve Spleen Volume Reduction Of 35% Or Greater (SVR35)
Description
Reduction in spleen volume is measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
Time Frame
Up To Week 24
Title
Maximum Observed Plasma Concentration (Cmax) of ABBV-744
Description
Maximum observed plasma concentration (Cmax) of ABBV-744.
Time Frame
Up To Week 12
Title
Time To Cmax (Tmax) Of ABBV-744
Description
The amount of time taken to reach Cmax.
Time Frame
Up To Week 12
Title
Area Under The Concentration Versus Time Curve (AUC) Of ABBV-744
Description
AUC of ABBV-744 will be calculated.
Time Frame
Up To Week 12
Title
Half-Life (t1/2) Of ABBV-744
Description
Half-life of ABBV-744 will be calculated.
Time Frame
Up To Week 12
Title
Accumulation Ratio Of ABBV-744
Description
Pharmacokinetic parameters will include accumulation ratio of ABBV-744.
Time Frame
Up To Week 12
Title
Apparent Clearance (CL/F) Of ABBV-744
Description
CL/F of ABBV-744 will be calculated.
Time Frame
Up To Week 12
Title
Apparent Volume Of Distribution (Vd/F) Of ABBV-744
Description
Vd/F of ABBV-744 will be calculated.
Time Frame
Up To Week 12
Title
Percentage Of Participants With >= 50% Reduction In Total Symptom Score (TSS)
Description
TSS is assessed using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. MFSAF v4.0 measures the burden of myelofibrosis-related symptoms. The symptoms are assessed on a 11-point numeric rating scale (NRS) anchored from 0 (absent) to 10 (worst imaginable).
Time Frame
Up to Week 24
Title
Objective Response Rate (ORR)
Description
ORR is defined as the sum of rates of partial remission (PR) or better.
Time Frame
Week 24
Title
Maximum Observed Plasma Concentration (Cmax) Of Navitoclax
Description
Maximum Observed Plasma Concentration (Cmax) Of Navitoclax.
Time Frame
Up To Week 12
Title
Time To Cmax (Tmax) Of Navitoclax
Description
The amount of time taken to reach Cmax.
Time Frame
Up To Week 12
Title
Area Under The Concentration Versus Time Curve (AUC) Of Navitoclax
Description
AUC of Navitoclax will be calculated.
Time Frame
Up To Week 12
Title
Maximum Observed Plasma Concentration (Cmax) Of Ruxolitinib
Description
Maximum Observed Plasma Concentration (Cmax) Of Ruxolitinib.
Time Frame
Up To Week 12
Title
Time To Cmax (Tmax) Of Ruxolitinib
Description
The amount of time taken to reach Cmax.
Time Frame
Up To Week 12
Title
Area Under The Concentration Versus Time Curve (AUC) Of Ruxolitinib
Description
AUC of Ruxolitinib will be calculated.
Time Frame
Up To Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Laboratory values indicative of adequate bone marrow, renal, and hepatic function meeting protocol criteria. Completion of the Myelofibrosis System Assessment Form (MFSAF) on at least 4 out of the 7 days prior to Day 1 with at least 2 symptoms with a score >=3 or a total score of >=10. Documented diagnosis of intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocytopenia MF (PET-MF) as defined by the World Health Organization (WHO). Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2. Intermediate - 2, or High-Risk disease as defined by the Dynamic International Prognostic Scoring System (For Segment A only, Intermediate - 1 with palpable splenomegaly >=5 centimeters [cm] below costal margin are also eligible). Splenomegaly defined as spleen palpation measurement >= 5 cm below costal margin or spleen volume >= 450 cubic cms as assessed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan (for Segments A and C, baseline spleen assessment must be obtained > 7 days after discontinuation of most recent Myelofibrosis (MF) therapy. If possible, this assessment should occur within 10 days of Cycle 1 Day 1). Segment-Specific Prior Therapy Criteria: Segment A: Prior exposure to one or more Janus Kinase inhibitors (JAKi),[the most recent of which was discontinued > 14 days prior to Cycle 1 Day 1] and are intolerant, resistant, refractory or lost response to the JAKi. Segment B: Currently receiving ruxolitinib AND Willingness to reduce ruxolitinib dose (if on a higher dose); and on a stable dose for 14 days or longer prior to Cycle 1 Day 1; AND At least one of the following criteria (a, b, or c): >= 24 weeks duration of current ruxolitinib course, with evidence of disease that is resistant, refractory, or has lost response to ruxolitinib therapy; < 24 weeks duration of current ruxolitinib course with documented resistance, refractories, or loss of response, as defined by any of the following: Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM), in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib. >=100% increase in the palpable distance below the LCM, in participants with measurable spleen distance 5 - 10 cm prior to the initiation of ruxolitinib. >=50% increase in the palpable distance below the LCM, in participants with measurable spleen > 10 cm prior to the initiation of ruxolitinib. A spleen volume increase >= 25% (as assessed by MRI or CT) in participants with a spleen volume assessment available prior to the initiation of ruxolitinib. Prior treatment with ruxolitinib for >= 28 days complicated by any of the following: Development of red blood cell transfusion requirement (at least 2 units/month for 2 months). Grade >= 3 adverse events of neutropenia and/or anemia while on ruxolitinib treatment, with improvement or resolution upon dose reduction. Segment C: Prior exposure to one or more JAKi (the most recent of which was discontinued > 14 days prior to Cycle 1 Day 1), and are intolerant, resistant, refractory or lost response to the JAKi. Exclusion Criteria: Segment-Specific Prior Therapy Criteria: Segment A: Prior exposure to one or more Bromodomain and Extra-Terminal (BET) inhibitors. Segment B: Prior exposure to one or more BET inhibitors. Segment C: Prior exposure to one or more BET inhibitors and/or any B-Cell Lymphoma 2 (BCL)-2 and/or BCL- XL inhibitor, including navitoclax. Segment D: Prior exposure to JAKi and/or any BET inhibitor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Davis Comprehensive Cancer Center /ID# 221790
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 224623
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Roswell Park Comprehensive Cancer Center /ID# 222557
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
The Mount Sinai Hospital /ID# 221549
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Cornell Medical College /ID# 227069
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 222802
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University of Oklahoma, Stephenson Cancer Center /ID# 224095
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104-5418
Country
United States
Facility Name
Oregon Health and Science Univ /ID# 221801
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 240004
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-2003
Country
United States
Facility Name
VA Puget Sound Health Care System /ID# 224208
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1597
Country
United States
Facility Name
Hospital Universitario Austral /ID# 228909
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires /ID# 226945
City
Ciudad Autonoma Buenos Aires
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1199
Country
Argentina
Facility Name
Townsville University Hospital /ID# 225859
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Royal Hobart Hospital /ID# 241677
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Royal Perth Hospital /ID# 241678
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Hospital das Clinicas da Universidade Federal de Goiás /ID# 226636
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605-020
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 226635
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 226640
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 226637
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência /ID# 226641
City
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226639
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
SHAT Hematologic Diseases /ID# 226007
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
UMHAT Sveta Marina /ID# 226681
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Icegclinic /Id# 231086
City
La Florida
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
8241479
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez /ID# 225037
City
Providencia
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Sociedad de Investigaciones Médicas Limitada /ID# 224175
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Clinexpert Kft. Fazis I Vizsgalohely /ID# 242249
City
Gyongyos
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 224085
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
The Chaim Sheba Medical Center /ID# 222151
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 223548
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 243852
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244397
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Kyushu University Hospital /ID# 228035
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hokkaido University Hospital /ID# 228038
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Osaka Metropolitan University Hospital /ID# 225502
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
University of Yamanashi Hospital /ID# 225503
City
Chuo-shi
State/Province
Yamanashi
ZIP/Postal Code
409-3821
Country
Japan
Facility Name
Inje University Busan Paik Hospital /ID# 233707
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Hospital Santa Creu i Sant Pau /ID# 238501
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 233279
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Orebro Universitetssjukhuset /ID# 228514
City
Orebro
State/Province
Orebro Lan
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Akademiska Sjukhuset /ID# 228515
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 234215
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 234214
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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