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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
AbbVie
Study ID
NCT02391480
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-075 — DRUG
    ABBV-075 Oral tablets
  • Venetoclax — DRUG
    Venetoclax tablets, film-coated

Study Details

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.

Key Dates

Start date
Apr 14, 2015
Status verified
Jul 2019
Primary completion
Jul 5, 2019
Completion
Jul 5, 2019

Study Design

Enrollment
128 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ABBV-075
    Dose escalation cohorts of ABBV-075 monotherapy
  • Experimental: ABBV-075 and venetoclax combination
    Expansion cohorts of ABBV-075 and venetoclax combination therapy
  • Experimental: ABBV-075 expansion
    Expansion cohorts of ABBV-075 monotherapy

Primary Outcome Measure

Maximum Tolerated Dose of ABBV-075 [ Time Frame: Minimum first cycle of dosing (28 days) up to one year for dose escalation segment. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Scottsdale Healthcare /ID# 132963ScottsdaleArizona85258-4566-
City of Hope /ID# 154053DuarteCalifornia91010-
UC Davis Comp Cancer Ctr /ID# 154644SacramentoCalifornia95817-
Yale University /ID# 136982New HavenConnecticut06510-
University of Chicago /ID# 155453ChicagoIllinois60637-1443-
Indiana Univ School Medicine /ID# 132946IndianapolisIndiana46202-
Duke Univ Med Ctr /ID# 154647DurhamNorth Carolina27705-
Mary Crowley Cancer Research /ID# 154059DallasTexas75230-
Univ TX, MD Anderson /ID# 132276HoustonTexas77030-
UT MD Anderson Cancer Center /ID# 164122HoustonTexas77030-

Find similar trials in Scottsdale, AZ

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By research site
Scottsdale Healthcare· Scottsdale, AZCity of Hope· Duarte, CAUC Davis Comp Cancer Ctr· Sacramento, CAYale University· New Haven, CTUniversity of Chicago· Chicago, ILIndiana Univ School Medicine· Indianapolis, IN

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