Loading clinical trials...

A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)

NCT03360006•AbbVie

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must have AML not amenable to curative therapy, refractory to standard of care therapy or for which standard of care therapy does not exist. Participants who are candidates for stem cell transplantation must have been offered this therapeutic option.
•Must consent to provide biomarker analyses as described in the protocol.
•Must have an Eastern Cooperative Oncology Group (ECOG) Performance status of:
•* Dose Escalation (Segment 1): 0 - 1
•* Dose Expansion (Segment 2): 0 - 2
•Dose Escalation: Must have a serum albumin during Screening of \>= 3.0 g/dL.
•Participant has adequate bone marrow, renal and hepatic function.

Exclusion Criteria

•Participant with known active Central Nervous System (CNS) disease.
•Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to ABBV-744 dosing. Saw palmetto is considered anti-cancer herbal remedy. Participant has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to Study Day 1. Except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis.
•Participant has been previously treated with a Bromodomain and Extra-Terminal (BET) inhibitor
•Participant has unresolved clinically significant toxicities from most recent prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.03) grade 2 or higher clinically significant toxicity (excluding alopecia).
•Participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, CYP3A inhibitors, CYP3A inducers.
•Participant consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
•Participant had major surgery within 28 days prior to Study Day 1.
•Participant is unable to swallow or absorb oral tablets.
•Participant has known infection with hepatitis B or hepatitis C.
•Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis, enteritis, colitis.
+2 more criteria

Locations (7)

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

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

Key Dates

Start Date

March 16, 2018

Primary Completion Date

December 19, 2020

Completion Date

December 19, 2020

Last Updated

March 24, 2021

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia (AML)

Interventions

ABBV-744

DRUG

BCL2i CLAG-M in R/R Acute Myeloid Leukemia

NCT06660368

Relapsed or Refractory Acute Myeloid Leukemia (AML)

View study

RECRUITINGPHASE1

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

NCT05143996

Relapsed/Refractory Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer

Inclusion Criteria

Exclusion Criteria

BCL2i CLAG-M in R/R Acute Myeloid Leukemia

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies

Study on Optimizing the Treatment of Patients With Acute Myeloid Leukemia Based on Early Peripheral Blood Minimal Residual Disease