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

NCT ID: NCT02391480

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-14
• Study Completion Date: 2019-07-05

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.

Conditions

Cancer; Breast Cancer; Non-Small Cell Lung Cancer; Acute Myeloid Leukemia (AML); Multiple Myeloma; Prostate Cancer; Small Cell Lung Cancer; Non-Hodgkins Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABBV-075

Dose escalation cohorts of ABBV-075 monotherapy

Group Type: EXPERIMENTAL

ABBV-075

Intervention Type: DRUG

ABBV-075 Oral tablets

ABBV-075 and venetoclax combination

Expansion cohorts of ABBV-075 and venetoclax combination therapy

Group Type: EXPERIMENTAL

ABBV-075

Intervention Type: DRUG

ABBV-075 Oral tablets

Venetoclax

Intervention Type: DRUG

Venetoclax tablets, film-coated

ABBV-075 expansion

Expansion cohorts of ABBV-075 monotherapy

Group Type: EXPERIMENTAL

ABBV-075

Intervention Type: DRUG

ABBV-075 Oral tablets

Interventions

ABBV-075

ABBV-075 Oral tablets

Intervention Type: DRUG

Venetoclax

Venetoclax tablets, film-coated

Intervention Type: DRUG

Other Intervention Names

Mivebresib; Venclexta

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts)

4. Participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dL at screening.

5. Adequate bone marrow, renal, and hepatic function.

6. QTc interval < 480 milliseconds (msec) on the baseline electrocardiogram.

Exclusion Criteria

1. Participant has untreated brain or meningeal metastases.

2. 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.

3. Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.

4. Symptoms of gross hematuria or gross hemoptysis.

5. Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg).

6. History of long QT syndrome.

7. Peripheral neuropathy greater than or equal to grade 2.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Scottsdale Healthcare /ID# 132963

Scottsdale, Arizona, United States

City of Hope /ID# 154053

Duarte, California, United States

UC Davis Comp Cancer Ctr /ID# 154644

Sacramento, California, United States

Yale University /ID# 136982

New Haven, Connecticut, United States

University of Chicago /ID# 155453

Chicago, Illinois, United States

Indiana Univ School Medicine /ID# 132946

Indianapolis, Indiana, United States

Duke Univ Med Ctr /ID# 154647

Durham, North Carolina, United States

Mary Crowley Cancer Research /ID# 154059

Dallas, Texas, United States

Univ TX, MD Anderson /ID# 132276

Houston, Texas, United States

UT MD Anderson Cancer Center /ID# 164122

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31420359 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33934351 (View on PubMed)

Other Identifiers

M14-546

Identifier Type: -

Identifier Source: org_study_id