158
Participants
Start Date
June 27, 2013
Primary Completion Date
October 28, 2020
Study Completion Date
December 15, 2020
ABT-199 (Main Cohort)
Participants received a test dose of ABT-199 of ≤ 20 mg on Week 1 Day 1 of the Lead-In Period. For those with significant electrolyte and/or lymphocyte changes within 24 hours of the first dose, the 20 mg dose was maintained for 7 days with escalation to 50 mg on Week 2 Day 1. If none of the electrolyte and/or lymphocyte changes occurred within 24 hours from ABT-199 20 mg dose administration, the participant was dose-escalated to 50 mg on Week 1 Day 2. After the first dose of 50 mg, if no laboratory abnormalities occurred, the participant remained on the 50 mg dose through Week 1. After receiving the 50 mg dose for approximately 1 week (6 to 7 days), the following dose escalation proceeded with weekly increases in dose: → 100 mg → 200 mg → 400 mg (or additional lead-in steps to designated 400 mg dose), as tolerated.
ABT-199 (Safety Expansion Cohort)
Participants received an initial dose of ABT-199 of 20 mg on Week 1 Day 1 of the Lead-In Period. If one or more electrolyte changes (from the 0 hr measurement prior to dosing) suggestive of laboratory tumor lysis syndrome (LTLS) or clinical TLS (CTLS) occurred within 24 hours of the 20 mg dose, no additional doses were administered until resolution. Upon resolution of laboratory abnormalities, the 20 mg dose was continued through Week 1. If no significant findings suggestive of clinical or laboratory TLS occurred within 24 hours, the 20 mg dose was continued through Week 1 Day 7, and escalated to a dose of 50 mg on Week 2 Day 1. Those who had drug interruptions may have been allowed to escalate to and be maintained at 50 mg for 1 week after they had been on a 20 mg dose for at least 1 week (5 - 7 days). After a week at 50 mg, weekly dose escalations were implemented as follows: 100 mg → 200 mg → 400 mg (or additional lead-in steps to designated 400 mg dose) as tolerated.
Royal North Shore Hospital /ID# 98836, St Leonards
Peter MacCallum Cancer Ctr /ID# 91795, Melbourne
Royal Melbourne Hospital /ID# 91794, Parkville
John Fawkner Private Hospital /ID# 98835, Coburg
Georgetown University Hospital /ID# 96954, Washington D.C.
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 113235, Kiel
Universitaetsmedizin Goettingen /ID# 113258, Göttingen
Cleveland Clinic Main Campus /ID# 92495, Cleveland
Henry Ford Health System /ID# 97795, Detroit
Uniklinik Koeln /ID# 98847, Cologne
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 113236, Mainz
Ingalls Memorial Hosp /ID# 92497, Harvey
Universitaetsklinik Heidelberg /ID# 98845, Heidelberg
Centre Hospitalier Lyon Sud /ID# 98839, Pierre-Bénite
Hopital Pitie Salpetriere /ID# 98842, Paris
Centre Henri Becquerel /ID# 98838, Rouen
University of Texas MD Anderson Cancer Center /ID# 92521, Houston
Universitaetsklinikum Freiburg /ID# 113276, Freiburg im Breisgau
Muenchen Klinik Schwabing /ID# 113275, München
Universitaetsklinikum Ulm /ID# 92533, Ulm
City of Hope /ID# 112875, Duarte
Moore UC San Diego Cancer Center /ID# 91793, La Jolla
Hopital Avicenne - APHP /ID# 98840, Bobigny
University of Arizona Cancer Center - North Campus /ID# 96748, Tucson
Stanford University School of Med /ID# 105117, Stanford
Northwestern University Feinberg School of Medicine /ID# 92499, Chicago
The University of Chicago Medical Center /ID# 96960, Chicago
Dana-Farber Cancer Institute /ID# 92494, Boston
Hackensack Univ Med Ctr /ID# 92500, Hackensack
Rutgers Cancer Institute of New Jersey /ID# 92513, New Brunswick
Columbia Univ Medical Center /ID# 103835, New York
Columbia Univ Medical Center /ID# 94716, New York
Duplicate_Jewish General Hospital /ID# 99476, Montreal
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 113256, Dresden
SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 98849, Krakow
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 98848, Lublin
Szpital Wojewodzki w Opolu /ID# 102855, Opole
Leicester Royal Infirmary /ID# 98865, Leicester
The Royal Bournemouth Hospital /ID# 118975, Bournemouth
Addenbrookes Hospital /ID# 119977, Cambridge
St. James University Hospital /ID# 98863, Leeds
Royal Liverpool and Broadgreen /ID# 98860, Liverpool
St Bartholomew's Hospital, Bar /ID# 98862, London
King's College Hospital NHS Foundation Trust /ID# 119975, London
The Christie Hospital /ID# 98864, Manchester
Oxford Univ Hosp NHS Trust /ID# 119976, Oxford
Derriford Hospital /ID# 118335, Plymouth
Royal Marsden Hospital /ID# 98861, Sutton
Lead Sponsor
Collaborators (1)
Genentech, Inc.
INDUSTRY
AbbVie
INDUSTRY