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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02391480
Recruitment Status : Active, not recruiting
First Posted : March 18, 2015
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Cancer Breast Cancer Non-Small Cell Lung Cancer Acute Myeloid Leukemia (AML) Multiple Myeloma Prostate Cancer Small Cell Lung Cancer Non-Hodgkins Lymphoma Drug: ABBV-075 Drug: Venetoclax Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer
Actual Study Start Date : April 14, 2015
Estimated Primary Completion Date : October 22, 2019
Estimated Study Completion Date : October 22, 2019


Arm Intervention/treatment
Experimental: ABBV-075
Dose escalation cohorts of ABBV-075 monotherapy
Drug: ABBV-075
ABBV-075 Oral tablets
Other Name: Mivebresib

Experimental: ABBV-075 and venetoclax combination
Expansion cohorts of ABBV-075 and venetoclax combination therapy
Drug: ABBV-075
ABBV-075 Oral tablets
Other Name: Mivebresib

Drug: Venetoclax
Venetoclax tablets, film-coated
Other Name: Venclexta

Experimental: ABBV-075 expansion
Expansion cohorts of ABBV-075 monotherapy
Drug: ABBV-075
ABBV-075 Oral tablets
Other Name: Mivebresib




Primary Outcome Measures :
  1. Maximum Tolerated Dose of ABBV-075 [ Time Frame: Minimum first cycle of dosing (28 days) up to one year for dose escalation segment. ]
    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.

  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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 14, 17, 20 hours post dose. ]
    Area under the plasma concentration versus time curve from time 0 (pre-dose) to the time of the last measurable concentration (AUC 0-t).


Secondary Outcome Measures :
  1. 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. ]
    DOR is defined as the time from the participant's initial CR or PR to the time of disease progression

  2. 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. ]
    ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR).

  3. 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. ]
    PFS is defined as the time from the first dose of ABBV-075 to either disease progression or death, whichever occurs first.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391480


Locations
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United States, Arizona
Scottsdale Healthcare /ID# 132963
Scottsdale, Arizona, United States, 85258-4566
United States, California
City of Hope /ID# 154053
Duarte, California, United States, 91010
UC Davis Comp Cancer Ctr /ID# 154644
Sacramento, California, United States, 95817
United States, Connecticut
Yale University /ID# 136982
New Haven, Connecticut, United States, 06510
United States, Illinois
University of Chicago /ID# 155453
Chicago, Illinois, United States, 60637-1443
United States, Indiana
Indiana Univ School Medicine /ID# 132946
Indianapolis, Indiana, United States, 46202
United States, North Carolina
Duke Univ Med Ctr /ID# 154647
Durham, North Carolina, United States, 27710
United States, Texas
Mary Crowley Cancer Research /ID# 154059
Dallas, Texas, United States, 75246
Univ TX, MD Anderson /ID# 132276
Houston, Texas, United States, 77030
UT MD Anderson Cancer Center /ID# 164122
Houston, Texas, United States, 77030
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02391480     History of Changes
Other Study ID Numbers: M14-546
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Cancer
Bromodomain Inhibitor

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Leukemia, Myeloid, Acute
Multiple Myeloma
Lymphoma, Non-Hodgkin
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases