This is an open-label, Phase 1, dose-escalation (Segment 1) and expansion (Segment 2) study to determine the maximum tolerated dose (MTD) and/or the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-744 in participants with relapsed/refractory Acute Myeloid Leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tablet, oral
UC Irvine /ID# 160789
Orange, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 202729
Sacramento, California, United States
Northwestern /ID# 171098
Chicago, Illinois, United States
University of Chicago DCAM /ID# 160702
Chicago, Illinois, United States
Maximum observed plasma concentration (Cmax) of ABBV-744
Cmax of ABBV-744.
Time frame: Through Cycle 2 ( each cycle is 28 days)
Time to Cmax (Tmax) of ABBV-744
Tmax of ABBV-744.
Time frame: Through Cycle 2 ( each cycle is 28 days)
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-744
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-744.
Time frame: Through Cycle 2 ( each cycle is 28 days)
Terminal Phase Elimination Rate Constant (β) of ABBV-744
Terminal Phase Elimination Rate Constant (β) of ABBV-744.
Time frame: Through Cycle 2 ( each cycle is 28 days)
Area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUCinf) of ABBV-744
Area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUCinf) of ABBV-744.
Time frame: Through Cycle 2 ( each cycle is 28 days)
Dose-limiting toxicity (DLT) of ABBV-744
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications and occurring during the first 4 weeks after administration of the first dose and that meets additional criteria as described in the protocol.
Time frame: Up to 28 days after first dose of study drug
Maximum Tolerated Dose (MTD) for ABBV-744
The MTD is defined as the highest dose for which the estimated posterior mean DLT rate is \<= 33% and excessive toxicity probability is limited to maximum of 25% during the first 28 days.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cleveland Clinic Main Campus /ID# 160756
Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center /ID# 160701
Houston, Texas, United States
Swedish-Center for Blood Disor /ID# 166487
Seattle, Washington, United States
Time frame: Up to 28 days after first dose of study drug
Recommended Phase 2 Dose (RPTD) for ABBV-744
RPTD will be determined from a review available safety, pharmacokinetic, and efficacy data during the dose escalation phase (Segment 1) of the study.
Time frame: Up to 28 days after first dose of study drug
Composite complete remission (CRc)
Percentage of participants who achieve composite complete remission (CRc), comprised of complete remission (CR) + CR with incomplete blood count recovery (CRi) is based on the International Working Group (IWG) criteria and European Leukemia Net criteria.
Time frame: Up to 2 years
Complete Remission (CR) + CR with partial hematologic recovery (CRh)
Percentage of participants who achieve CR + CR with partial hematologic recovery (CRh) is based on the International Working Group (IWG) criteria and European Leukemia Net criteria.
Time frame: Up to 2 years
Objective Response Rate (ORR)
Percentage of participants who achieve ORR \[composite complete remission (CRc) + Partial remission (PR)\] is based on the International Working Group (IWG) criteria (CRc, PR) and European Leukemia Net criteria.
Time frame: Up to 2 years
Duration of Response (DOR)
DOR is defined as the number of days from the date of first response to the first occurrence of progression or death from any cause, whichever occurs first.
Time frame: Up to 2 years
Event-free survival (EFS)
Percentage of participants who achieve EFS, where EFS is defined as the date of first dose of study drug to the date of primary refractory disease, relapse from CR or CRi, or death from any cause.
Time frame: Up to 2 years