NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedMyelofibrosis
Date of first enrollment22/03/2021
Target sample size130
Countries of recruitmentUnited States,Hungary,Israel,Chile,Japan
Study typeInterventional
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 OutcomePercentage of Participants With Adverse Events
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
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 criteriaSegment-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

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
E-mail 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
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie G.K.