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NCT Number: NCT02391480

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

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.

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Key information

Conditions

Cancer Acute Myeloid Leukemia (AML) Blood Protein Disorders Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiovascular Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Non-Hodgkins Lymphoma Non-small Cell Lung Cancer Paraproteinemias Prostate Cancer Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scottsdale Healthcare /ID# 132963, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts)
  • Participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dL at screening.
  • Adequate bone marrow, renal, and hepatic function.
  • QTc interval < 480 milliseconds (msec) on the baseline electrocardiogram.

Exclusion criteria

  • Participant has untreated brain or meningeal metastases.
  • 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.
  • Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  • Symptoms of gross hematuria or gross hemoptysis.
  • Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg).
  • History of long QT syndrome.
  • Peripheral neuropathy greater than or equal to grade 2.

Treatment and study plan

ABBV-075

Drug

ABBV-075 Oral tablets

Other names: Mivebresib

Venetoclax

Drug

Venetoclax tablets, film-coated

Other names: Venclexta

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2015
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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