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CancerPhase 1NCT02391480

A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer

A Phase 1 study testing ABBV-075 and Venetoclax in people with Cancer and Breast Cancer, run by AbbVie at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Breast Cancer, Non-Small Cell Lung Cancer
What is being tested?
ABBV-075 and Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
10 sitesUnited States
Study dates
14 Apr 2015to 5 Jul 2019
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 in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist.
  • Participants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts)
  • Participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dL at screening.
  • Adequate bone marrow, renal, and hepatic function.
  • QTc interval < 480 milliseconds (msec) on the baseline electrocardiogram.

Who cannot join

  • Participant has untreated brain or meningeal metastases.
  • Participant has received anti-cancer therapy including chemotherapy, immunotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1.
  • Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  • Symptoms of gross hematuria or gross hemoptysis.
  • Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg).
  • History of long QT syndrome.
  • Peripheral neuropathy greater than or equal to grade 2.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Chicago /ID# 155453

    Chicago, Illinois, 60637-1443

  • Mary Crowley Cancer Research /ID# 154059

    Dallas, Texas, 75230

  • City of Hope /ID# 154053

    Duarte, California, 91010

  • Duke Univ Med Ctr /ID# 154647

    Durham, North Carolina, 27705

  • Univ TX, MD Anderson /ID# 132276

    Houston, Texas, 77030

  • UT MD Anderson Cancer Center /ID# 164122

    Houston, Texas, 77030

  • Indiana Univ School Medicine /ID# 132946

    Indianapolis, Indiana, 46202

  • Yale University /ID# 136982

    New Haven, Connecticut, 06510

  • UC Davis Comp Cancer Ctr /ID# 154644

    Sacramento, California, 95817

  • Scottsdale Healthcare /ID# 132963

    Scottsdale, Arizona, 85258-4566

Other trials in United States

About this study

Official title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer

This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.

Being tested
ABBV-075, Venetoclax
Keywords
Cancer, Bromodomain Inhibitor
Medical subject headings
Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Leukemia, Myeloid, Acute, Multiple Myeloma, Prostatic Neoplasms, Small Cell Lung Carcinoma, Lymphoma, Non-Hodgkin

What participants receive

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

  • ABBV-075Drug

    Also called Mivebresib

    ABBV-075 Oral tablets

  • VenetoclaxDrug

    Also called Venclexta

    Venetoclax tablets, film-coated

Study groups in NCT02391480
Study groupRoleWhat they receive
ABBV-075ExperimentalDose escalation cohorts of ABBV-075 monotherapy
Receives: Drug: ABBV-075
ABBV-075 and venetoclax combinationExperimentalExpansion cohorts of ABBV-075 and venetoclax combination therapy
Receives: Drug: ABBV-075; Drug: Venetoclax
ABBV-075 expansionExperimentalExpansion cohorts of ABBV-075 monotherapy
Receives: Drug: ABBV-075

What is being measured

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

  1. Maximum Tolerated Dose of ABBV-075

    Maximum tolerated dose is defined as the highest dose level at which less than 2 of 6 participants experience the same dose limiting toxicity. If more than 2 participants experience a different dose limiting toxicity, the maximum tolerated dose may be further evaluated or determined to be exceeded based on discussions with the investigators and medical monitors.

    Measured: Minimum first cycle of dosing (28 days) up to one year for dose escalation segment.

  2. Time to Cmax (peak time, Tmax) for ABBV-075

    Measured: Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.

  3. Number of participants with adverse events

    Measured: Screening, Cycle 1 Day 1, 8 and 15, then Day 1 of each cycle up to approximately 2 years.

  4. Maximum observed plasma concentration (Cmax) of ABBV-075

    Measured: Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.

  5. Area under the curve (AUC)

    Area under the plasma concentration versus time curve from time 0 (pre-dose) to the time of the last measurable concentration (AUC 0-t).

    Measured: Cycle 1 Day 1 Pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post ABBV-075 dosing, and on Cycle 1 Day 15 at 14, 17, 20 hours post dose.

Secondary outcomes (3)

  1. Duration of overall response (DOR)

    DOR is defined as the time from the participant's initial CR or PR to the time of disease progression

    Measured: At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.

  2. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).

    Measured: At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.

  3. Progression Free Survival (PFS)

    PFS is defined as the time from the first dose of ABBV-075 to either disease progression or death, whichever occurs first.

    Measured: Screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 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 posted18 Mar 2015 (estimated)
  2. Study start14 Apr 2015
  3. Primary completion5 Jul 2019
  4. Study completion5 Jul 2019

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
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02391480
Sponsor's protocol ID
M14-546
Status last verified
Jul 2019
First submitted
12 Mar 2015
Last updated
29 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN Jr, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clin Cancer Res. 2019 Nov 1;25(21):6309-6319. doi: 10.1158/1078-0432.CCR-19-0578. Epub 2019 Aug 16.

    PubMed 31420359

  • Borthakur G, Odenike O, Aldoss I, Rizzieri DA, Prebet T, Chen C, Popovic R, Modi DA, Joshi RH, Wolff JE, Jonas BA. A phase 1 study of the pan-bromodomain and extraterminal inhibitor mivebresib (ABBV-075) alone or in combination with venetoclax in patients with relapsed/refractory acute myeloid leukemia. Cancer. 2021 Aug 15;127(16):2943-2953. doi: 10.1002/cncr.33590. Epub 2021 May 2.

    PubMed 33934351

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-075 and Venetoclax in people with Cancer and Breast Cancer, run by AbbVie at 10 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Tolerated Dose of ABBV-075 (time frame: Minimum first cycle of dosing (28 days) up to one year for dose escalation segment.). The study lists 5 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 NCT02391480, 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 29 Nov 2019.

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