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

Status: Closed to Accrual

Description

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.

Eligibility Criteria

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
  • 3. 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.

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available

Connecticut

New Haven
Yale University
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: In review
Name Not Available
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Temporarily closed to accrual
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Abbvie

Trial IDs

Primary ID M14-546
Secondary IDs NCI-2015-00707
Clinicaltrials.gov ID NCT02391480