Clinical Trials /

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

NCT03360006

Description:

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).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Participants With Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer
  • Official Title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Clinical Trial IDs

  • ORG STUDY ID: M16-415
  • NCT ID: NCT03360006

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DrugSynonymsArms
ABBV-744ABBV-744 Dose Escalation

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
ABBV-744 Dose EscalationExperimentalABBV-744 will be administered at escalating dose levels until the maximum tolerated dose is reached and a recommended Phase 2 dose is determined.
  • ABBV-744
ABBV-744 Dose ExpansionExperimentalABBV-744 will be administered at the recommended Phase 2 dose determined during the Dose Escalation phase.
  • ABBV-744

Eligibility Criteria

        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.

          -  Participant has symptoms of gross hematuria or gross hemoptysis

          -  Has electrocardiogram with a QT interval corrected for heart rate using Fridericia's
             formula (QTcF) > 470 msec or ECG with second degree type 2 or third degree
             atrioventricular block.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum observed plasma concentration (Cmax) of ABBV-744
Time Frame:Through Cycle 2 ( each cycle is 28 days)
Safety Issue:
Description:Cmax of ABBV-744.

Secondary Outcome Measures

Measure:Composite complete remission (CRc)
Time Frame:Up to 2 years
Safety Issue:
Description: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.
Measure:Complete Remission (CR) + CR with partial hematologic recovery (CRh)
Time Frame:Up to 2 years
Safety Issue:
Description: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.
Measure:Objective Response Rate (ORR)
Time Frame:Up to 2 years
Safety Issue:
Description: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.
Measure:Duration of Response (DOR)
Time Frame:Up to 2 years
Safety Issue:
Description: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.
Measure:Event-free survival (EFS)
Time Frame:Up to 2 years
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Acute Myeloid Leukemia (AML)
  • Relapsed/refractory acute myeloid leukemia
  • Dose-limiting toxicity
  • Recommended phase two dose
  • Pharmacokinetics

Last Updated

April 3, 2020