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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02391480
Collaborator
(none)
128
Enrollment
10
Locations
3
Arms
50.7
Actual Duration (Months)
12.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
128 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 :
Apr 14, 2015
Actual Primary Completion Date :
Jul 5, 2019
Actual Study Completion Date :
Jul 5, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABBV-075

Dose escalation cohorts of ABBV-075 monotherapy

Drug: ABBV-075
ABBV-075 Oral tablets
Other Names:
  • Mivebresib

    		•
    Experimental: ABBV-075 and venetoclax combination

    Expansion cohorts of ABBV-075 and venetoclax combination therapy

    Drug: ABBV-075
    ABBV-075 Oral tablets
    Other Names:
  • Mivebresib

    • Drug: Venetoclax
    Venetoclax tablets, film-coated
    Other Names:
  • Venclexta

    		•
    Experimental: ABBV-075 expansion

    Expansion cohorts of ABBV-075 monotherapy

    Drug: ABBV-075
    ABBV-075 Oral tablets
    Other Names:
  • Mivebresib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose of ABBV-075 [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 [Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.]

    3. 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.]

    4. Maximum observed plasma concentration (Cmax) of ABBV-075 [Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.]

    5. Area under the curve (AUC) [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) [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) [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

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

    5. Symptoms of gross hematuria or gross hemoptysis.

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

    7. History of long QT syndrome.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scottsdale Healthcare /ID# 132963 Scottsdale Arizona United States 85258-4566
    2 City of Hope /ID# 154053 Duarte California United States 91010
    3 UC Davis Comp Cancer Ctr /ID# 154644 Sacramento California United States 95817
    4 Yale University /ID# 136982 New Haven Connecticut United States 06510
    5 University of Chicago /ID# 155453 Chicago Illinois United States 60637-1443
    6 Indiana Univ School Medicine /ID# 132946 Indianapolis Indiana United States 46202
    7 Duke Univ Med Ctr /ID# 154647 Durham North Carolina United States 27705
    8 Mary Crowley Cancer Research /ID# 154059 Dallas Texas United States 75230
    9 Univ TX, MD Anderson /ID# 132276 Houston Texas United States 77030
    10 UT MD Anderson Cancer Center /ID# 164122 Houston Texas United States 77030

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02391480
    Other Study ID Numbers:
    • M14-546
    First Posted:
    Mar 18, 2015
    Last Update Posted:
    Nov 29, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Lung Neoplasms
    Leukemia, Myeloid, Acute
    Multiple Myeloma
    Small Cell Lung Carcinoma
    Venetoclax

    Study Results

    No Results Posted as of Nov 29, 2019