Spots Global Cancer Trial Database for Ixazomib Rollover Study
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Trial Identification
Brief Title: Ixazomib Rollover Study
Official Title: An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies
Study ID: NCT02924272
Interventions
Study Description
Brief Summary: The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.
Detailed 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 Takeda-sponsored clinical study, and in the investigator's opinion and approved by the Takeda medical monitor, may benefit from continued ixazomib therapy. The study will enroll approximately 250 patients. All participants will receive ixazomib as a single agent or in combination with other study drugs 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 is transitioned to ixazomib/other therapy 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 study drug for a safety assessment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Emory University, Atlanta, Georgia, United States
Appalachian Regional Healthcare, Hazard, Kentucky, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
UZ Leuven, Leuven, , Belgium
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Peking University Third Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
1st Affiliated Hospital of Zhejiang University, Hangzhou, , China
Shanghai Chang Zheng Hospital, Shanghai, , China
Laiko General Hospital of Athens, Athens, Attiki, Greece
University of Athens Medical School - Regional General Hospital Alexandra, Athens, , Greece
Tokyo Metropolitan Komagome Hospital, Bunkyo-Ku, Tokyo, Japan
Japanese Red Cross Medical Center, Shibuya-Ku, Tokyo, Japan
Asan Medical Center - PPDS, Seoul, , Korea, Republic of
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Chorzow, Slaskie, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz, , Poland
Centrum Onkologii Ziemi Lubelskiej, Lublin, , Poland
MTZ Clinical Research Sp z o o, Warszawa, , Poland
National University Hospital, Singapore, , Singapore
Complejo Asistencial Universitario de Salamanca H. Clinico, Salamanca, , Spain
Hospital Universitario de Donostia, San Sebastian, , Spain
Karolinska Universitetssjukhuset Huddinge, Stockholm, Sodermanlands Lan, Sweden
Skanes Universitetssjukhus Lund, Lund, , Sweden
Karolinska Universitetssjukhuset Solna, Stockholm, , Sweden
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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