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Acute Myeloid Leukemia (AML)Phase 1NCT03360006

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

A Phase 1 study testing ABBV-744 in people with Acute Myeloid Leukemia (AML), run by AbbVie at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
ABBV-744
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
7 sitesUnited States
Study dates
16 Mar 2018to 19 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Northwestern /ID# 171098

    Chicago, Illinois, 60611

  • University of Chicago DCAM /ID# 160702

    Chicago, Illinois, 60637-1443

  • Cleveland Clinic Main Campus /ID# 160756

    Cleveland, Ohio, 44195

  • University of Texas MD Anderson Cancer Center /ID# 160701

    Houston, Texas, 77030

  • UC Irvine /ID# 160789

    Orange, California, 92868

  • University of California, Davis Comprehensive Cancer Center /ID# 202729

    Sacramento, California, 95817

  • Swedish-Center for Blood Disor /ID# 166487

    Seattle, Washington, 98104

Other trials in United States

About this study

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

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).

Being tested
ABBV-744
Keywords
Acute Myeloid Leukemia (AML), Relapsed/refractory acute myeloid leukemia, Dose-limiting toxicity, Recommended phase two dose, Pharmacokinetics
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-744Drug

    Tablet, oral

Study groups in NCT03360006
Study groupRoleWhat they receive
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.
Receives: Drug: ABBV-744
ABBV-744 Dose ExpansionExperimentalABBV-744 will be administered at the recommended Phase 2 dose determined during the Dose Escalation phase.
Receives: Drug: ABBV-744

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed plasma concentration (Cmax) of ABBV-744

    Cmax of ABBV-744.

    Measured: Through Cycle 2 ( each cycle is 28 days)

  2. Time to Cmax (Tmax) of ABBV-744

    Tmax of ABBV-744.

    Measured: Through Cycle 2 ( each cycle is 28 days)

  3. 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.

    Measured: Through Cycle 2 ( each cycle is 28 days)

  4. Terminal Phase Elimination Rate Constant (β) of ABBV-744

    Terminal Phase Elimination Rate Constant (β) of ABBV-744.

    Measured: Through Cycle 2 ( each cycle is 28 days)

  5. 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.

    Measured: Through Cycle 2 ( each cycle is 28 days)

  6. 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.

    Measured: Up to 28 days after first dose of study drug

  7. 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.

    Measured: Up to 28 days after first dose of study drug

  8. 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.

    Measured: Up to 28 days after first dose of study drug

Secondary outcomes (5)

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. 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.

    Measured: Up to 2 years

  4. 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.

    Measured: Up to 2 years

  5. 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2017
  2. Study start16 Mar 2018
  3. Primary completion19 Dec 2020
  4. Study completion19 Dec 2020

Why it stopped: Strategic Reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03360006
Sponsor's protocol ID
M16-415
Status last verified
Mar 2021
First submitted
28 Nov 2017
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Crymes A, Evans MG, Jeyakumar D, Lou JJ, Zhao X, Rezk SA. Acute Myeloid Leukemia (AML) With T-Cell Differentiation Arising From Chronic Myelomonocytic Leukemia (CMML). Case Rep Hematol. 2024 Dec 14;2024:5584297. doi: 10.1155/crh/5584297. eCollection 2024.

    PubMed 39734743

  • Zhang L, Cai T, Lin X, Huang X, Bui MH, Plotnik JP, Bellin RJ, Faivre EJ, Kuruvilla VM, Lam LT, Lu X, Zha Z, Feng W, Hessler P, Uziel T, Zhang Q, Cavazos A, Han L, Ferguson DC, Mehta G, Shanmugavelandy SS, Magoc TJ, Rowe J, Goodwin NC, Dorritie KA, Boyiadzis M, Albert DH, McDaniel KF, Kati WM, Konopleva M, Shen Y. Selective Inhibition of the Second Bromodomain of BET Family Proteins Results in Robust Antitumor Activity in Preclinical Models of Acute Myeloid Leukemia. Mol Cancer Ther. 2021 Oct;20(10):1809-1819. doi: 10.1158/1535-7163.MCT-21-0029. Epub 2021 Jul 12.

    PubMed 34253595

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-744 in people with Acute Myeloid Leukemia (AML), run by AbbVie at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic Reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed plasma concentration (Cmax) of ABBV-744 (time frame: Through Cycle 2 ( each cycle is 28 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360006, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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