New Haven, Connecticut 06510

  • Hodgkins Lymphoma

Purpose:

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.


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.


Study is Available At:


Original ID:

M14-546


NCT ID:

NCT02391480


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AbbVie


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

128


Enrollment Type:

Actual


Overall Contact Information

Official Name:AbbVie Inc.
Study Director
AbbVie

Study Dates

Start Date:April 14, 2015
Completion Date:July 5, 2019
Completion Type:Actual
Primary Completion Date:July 5, 2019
Primary Completion Type:Actual
Verification Date:July 2019
Last Changed Date:November 27, 2019
First Received Date:March 12, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Progression Free Survival (PFS)
Time Frame:Screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Safety Issues:False
Description:PFS is defined as the time from the first dose of ABBV-075 to either disease progression or death, whichever occurs first.
Outcome Type:Secondary Outcome
Measure:Objective Response Rate (ORR)
Time Frame:At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Safety Issues:False
Description:ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).
Outcome Type:Secondary Outcome
Measure:Duration of overall response (DOR)
Time Frame:At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.
Safety Issues:False
Description:DOR is defined as the time from the participant's initial CR or PR to the time of disease progression
Outcome Type:Primary Outcome
Measure:Area under the curve (AUC)
Time Frame: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
Safety Issues:False
Description:Area under the plasma concentration versus time curve from time 0 (pre-dose) to the time of the last measurable concentration (AUC 0-t).
Outcome Type:Primary Outcome
Measure:Maximum observed plasma concentration (Cmax) of ABBV-075
Time Frame:Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of participants with adverse events
Time Frame:Screening, Cycle 1 Day 1, 8 and 15, then Day 1 of each cycle up to approximately 2 years.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Time to Cmax (peak time, Tmax) for ABBV-075
Time Frame:Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Safety Issues:False
Outcome Type: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.
Safety Issues:False
Description: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 fur

Study Interventions

Intervention Type:Drug
Name:ABBV-075
Description:ABBV-075 Oral tablets
Arm Name:ABBV-075
Other Name:Mivebresib
Intervention Type:Drug
Name:Venetoclax
Description:Venetoclax tablets, film-coated
Arm Name:ABBV-075 and venetoclax combination
Other Name:Venclexta

Study Arms

Study Arm Type:Experimental
Arm Name:ABBV-075 expansion
Description:Expansion cohorts of ABBV-075 monotherapy
Study Arm Type:Experimental
Arm Name:ABBV-075 and venetoclax combination
Description:Expansion cohorts of ABBV-075 and venetoclax combination therapy
Study Arm Type:Experimental
Arm Name:ABBV-075
Description:Dose escalation cohorts of ABBV-075 monotherapy

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AbbVie

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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:31420359

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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