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

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ClinicalTrials.gov Identifier: NCT02391480
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE March 12, 2015
First Posted Date  ICMJE March 18, 2015
Last Update Posted Date November 29, 2019
Actual Study Start Date  ICMJE April 14, 2015
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • 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.
  • 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. ]
  • 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. ]
  • 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. ]
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • 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.
  • 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. ]
  • 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. ]
  • 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. ]
  • 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • 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
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • 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).
  • 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.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer
Official Title  ICMJE A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Acute Myeloid Leukemia (AML)
  • Multiple Myeloma
  • Prostate Cancer
  • Small Cell Lung Cancer
  • Non-Hodgkins Lymphoma
Intervention  ICMJE
  • Drug: ABBV-075
    ABBV-075 Oral tablets
    Other Name: Mivebresib
  • Drug: Venetoclax
    Venetoclax tablets, film-coated
    Other Name: Venclexta
Study Arms  ICMJE
  • Experimental: ABBV-075
    Dose escalation cohorts of ABBV-075 monotherapy
    Intervention: Drug: ABBV-075
  • Experimental: ABBV-075 and venetoclax combination
    Expansion cohorts of ABBV-075 and venetoclax combination therapy
    Interventions:
    • Drug: ABBV-075
    • Drug: Venetoclax
  • Experimental: ABBV-075 expansion
    Expansion cohorts of ABBV-075 monotherapy
    Intervention: Drug: ABBV-075
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2019)
128
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2015)
78
Actual Study Completion Date  ICMJE July 5, 2019
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02391480
Other Study ID Numbers  ICMJE M14-546
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP