JRCT ID: jRCT2031210007
Registered date:02/04/2021
[M20-247] 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
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Myelofibrosis |
Date of first enrollment | 22/03/2021 |
Target sample size | 130 |
Countries of recruitment | United States,Japan,Hungary,Japan,Israel,Japan,Chile,Japan |
Study type | Interventional |
Intervention(s) | Segment A: ABBV-744 Dose Identification and Optimization 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. Segment A: ABBV-744 Monotherapy Participants will receive the identified safe dosing regimen of ABBV-744 as monotherapy. Segment B: Ruxolitinib + ABBV-744 "Add on" Therapy Participants whose disease (myelofibrosis) is inadequately controlled by ongoing ruxolitinib therapy will receive ruxolitinib and ABBV-744 as "add-on" therapy. Segment C: ABBV-744 + Navitoclax Participants who have previously been exposed to JAKi, and stopped such therapy, will receive ABBV-744 and navitoclax. Segment D: ABBV-744 + Ruxolitinib Participants who have never received JAKi will receive ABBV-744 and ruxolitinib. |
Outcome(s)
Primary Outcome | Percentage of Participants With Adverse Events |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 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): a) >= 24 weeks duration of current ruxolitinib course, with evidence of disease that is resistant, refractory, or has lost response to ruxolitinib monotherapy; b) < 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. c) 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. |
Exclude 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. |
Related Information
Primary Sponsor | Okubo Sumiko |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04454658 |
Contact
Public contact | |
Name | Contact for Patients and HCP |
Address | 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023 |
Telephone | +81-120-587-874 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie. G.K. |
Scientific contact | |
Name | Sumiko Okubo |
Address | 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023 |
Telephone | +81-120-587-874 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie G.K. |