A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer
NCT02391480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2019-11-29
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.
Conditions
- Cancer
- Breast Cancer
- Non-Small Cell Lung Cancer
- Acute Myeloid Leukemia (AML)
- Multiple Myeloma
- Prostate Cancer
- Small Cell Lung Cancer
- Non-Hodgkins Lymphoma
Interventions
- DRUG
-
ABBV-075
ABBV-075 Oral tablets
- DRUG
-
Venetoclax tablets, film-coated
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AbbVie Inc. · AbbVie
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-04-14
- Primary Completion
- 2019-07-05
- Completion
- 2019-07-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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