Last updated on June 2018

Ixazomib Rollover Study


Brief description of study

The purpose of this study is to provide continued access to ixazomib and evaluation of the long-term safety profile of ixazomib.

Detailed Study Description

The drug being tested in this study is called ixazomib. This study will look at the long term safety profile of ixazomib in participants who have previously received and tolerated ixazomib in a Millennium-sponsored clinical study, and in the investigator's opinion and confirmed by the Millennium medical monitor, may benefit from continued ixazomib therapy.

The study will enroll approximately 250 patients.

All participants will receive ixazomib at same dose and schedule that they were receiving in the parent study until they experience disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until ixazomib is available to the participant through commercial channels, including reimbursement for the participant's indication, whichever is sooner.

This multicenter, rollover study will be conducted worldwide. The overall time to participate in this study is up to 7 years. Participants will make multiple visits to the clinic, and a final visit after 30 days of last dose of ixazomib for a safety assessment.

Clinical Study Identifier: NCT02924272

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City of Hope National Medical Center
Duarte, CA United States
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Cedars Sinai Medical Center
Los Angeles, CA United States
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Mayo Clinic Jacksonville - PPDS
Jacksonville, FL United States
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Emory University
Atlanta, GA United States
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University of Chicago Medical Center
Chicago, IL United States
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Appalachian Regional Healthcare
Hazard, KY United States
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University of Maryland
Baltimore, MD United States
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Associates of Oncology/Hematology PC
Rockville, MD United States
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Dana Farber Cancer Institute
Boston, MA United States
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University of Michigan
Ann Arbor, MI United States
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Mayo Clinic - PPDS
Rochester, MN United States
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Washington University School of Medicine
Saint Louis, MO United States
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Cancer Institute of New Jersey
New Brunswick, NJ United States
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Mount Sinai Hospital - Canada
New York, NY United States
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Memorial Sloan Kettering Cancer Center
New York, NY United States
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New York Presbyterian Hospital - Weill-Cornell
New York, NY United States
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Weill Cornell Medical Center
New York, NY United States
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Mount Sinai Medical Center
New York, NY United States
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Rochester General Hospital
Rochester, NY United States
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Duke University Medical Center
Durham, NC United States
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Ohio State University
Columbus, OH United States
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Sarah Cannon Cancer Center
Nashville, TN United States
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SCRI Tennessee Oncology Nashville
Nashville, TN United States
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Houston Methodist Hospital
Houston, TX United States
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W VA University Mary Babb Randolph Cancer Center
Morgantown, WV United States
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The Medical College of Wisconsin, Inc.
Milwaukee, WI United States
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Royal Prince Alfred Hospital
Camperdown, Australia
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Concord Repatriation General Hospital
Concord, Australia
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Calvary Mater Newcastle
Waratah, Australia
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Royal Adelaide Hospital
Adelaide, Australia
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Austin Health
Heidelberg, Australia
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GasthuisZusters Antwerpen
Wilrijk, Belgium
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Princess Margaret Cancer Centre
Toronto, ON Canada
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University Health Network
Toronto, ON Canada
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Sir Mortimer B Davis Jewish General Hospital
Point-Claire, QC Canada
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Peking University Third Hospital
Beijing, China
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Peking Union Medical College Hospital
Beijing, China
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Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
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1st Affiliated Hospital of Zhejiang University
Hangzhou, China
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Shanghai Chang Zheng Hospital
Shanghai, China
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Vseobecna fakultni nemocnice v Praze
Prague, Czechia
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University General Hospital of Patras
Patra, Greece
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Evangelismos General Hospital of Athens
Athens, Greece
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Laiko General Hospital of Athens
Athens, Greece
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University of Athens Medical School - Regional General Hospital Alexandra
Athens, Greece
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Theageneio Anticancer Oncology Hospital of Thessaloniki
Thessaloniki, Greece
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Asan Medical Center - PPDS
Seoul, Korea, Republic of
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Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk, Poland
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Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzow, Poland
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Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Poland
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Centrum Onkologii Ziemi Lubelskiej
Lublin, Poland
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MTZ Clinical Research Sp z o o
Warszawa, Poland
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National University Hospital
Singapore, Singapore
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Complejo Asistencial Universitario de Salamanca H. Clinico
Salamanca, Spain
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Hospital Universitario de Donostia
San Sebastian, Spain
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Helsingborg Lasarett
Helsingborg, Sweden
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Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
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Skanes Universitetssjukhus Lund
Lund, Sweden
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Karolinska Universitetssjukhuset Solna
Stockholm, Sweden
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