A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer
1 other identifier
interventional
128
1 country
10
Brief 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. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started Apr 2015
Typical duration for phase_1 cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedStudy Start
First participant enrolled
April 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2019
CompletedNovember 29, 2019
July 1, 2019
4.2 years
March 12, 2015
November 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Minimum first cycle of dosing (28 days) up to one year for dose escalation segment.
Time to Cmax (peak time, Tmax) for ABBV-075
Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Number of participants with adverse events
Screening, Cycle 1 Day 1, 8 and 15, then Day 1 of each cycle up to approximately 2 years.
Maximum observed plasma concentration (Cmax) of ABBV-075
Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
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).
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)
Duration of overall response (DOR)
At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Objective Response Rate (ORR)
At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Progression Free Survival (PFS)
Screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Study Arms (3)
ABBV-075
EXPERIMENTALDose escalation cohorts of ABBV-075 monotherapy
ABBV-075 and venetoclax combination
EXPERIMENTALExpansion cohorts of ABBV-075 and venetoclax combination therapy
ABBV-075 expansion
EXPERIMENTALExpansion cohorts of ABBV-075 monotherapy
Interventions
ABBV-075 Oral tablets
Venetoclax tablets, film-coated
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (10)
Scottsdale Healthcare /ID# 132963
Scottsdale, Arizona, 85258-4566, United States
City of Hope /ID# 154053
Duarte, California, 91010, United States
UC Davis Comp Cancer Ctr /ID# 154644
Sacramento, California, 95817, United States
Yale University /ID# 136982
New Haven, Connecticut, 06510, United States
University of Chicago /ID# 155453
Chicago, Illinois, 60637-1443, United States
Indiana Univ School Medicine /ID# 132946
Indianapolis, Indiana, 46202, United States
Duke Univ Med Ctr /ID# 154647
Durham, North Carolina, 27705, United States
Mary Crowley Cancer Research /ID# 154059
Dallas, Texas, 75230, United States
Univ TX, MD Anderson /ID# 132276
Houston, Texas, 77030, United States
UT MD Anderson Cancer Center /ID# 164122
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 31420359RESULTBorthakur 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.
PMID: 33934351DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 18, 2015
Study Start
April 14, 2015
Primary Completion
July 5, 2019
Study Completion
July 5, 2019
Last Updated
November 29, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share