Spots Global Cancer Trial Database for Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials
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Trial Identification
Brief Title: Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials
Official Title: An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety of Lenvatinib Monotherapy or Lenvatinib Combination Regimen or Comparator Treatment Arm to Cancer Patients in Eisai Sponsored Lenvatinib Trials
Study ID: NCT03477175
Conditions
Study Description
Brief Summary: This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies.
Detailed Description: This is an open-label extension study to roll-over eligible participants from Eisai-sponsored lenvatinib studies. The participants may roll-over no sooner than the primary completion dates in their parent study or after all study data for the primary outcome measure have been collected for the parent study. The parent study is defined as the Eisai-sponsored lenvatinib clinical study in which the participant was receiving lenvatinib either as monotherapy or as combination therapy or was receiving any other comparator therapy. The participant can be enrolled in the current study for the purpose of long-term safety data collection if all the selection criteria for the current study are met. The intention is that the participant will not be without study drug during the transition from the parent study to the rollover study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Harbor UCLA Medical Center, Torrance, California, United States
Northwestern University, Chicago, Illinois, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
The Alfred Hospital, Melbourne, , Australia
UZ Antwerpen, Edegem, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, Brussels, Belgium
Sun Yat-sen University, Cancer Center, Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China
Harbin Medical University Cancer Hospital, Haerbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Nanjing First Hospital, Nanjing, Jiangsu, China
The First Hospital of Jilin University, Changchun, Jilin, China
No.10 People of Shanghai, Shanghai, Shanghai, China
West China School of Medicine/West China Hospital, Sichuan University, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Eisai trial site 2, Essen, , Germany
Eisai trial site 1, Würzburg, , Germany
Azienda Ospedaliero Universitaria Pisana, Pisa, Toscana, Italy
National Cancer Center, Goyang-si, Gyeonggido, Korea, Republic of
Samsung Medical Center - PPDS, Seoul, , Korea, Republic of
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, Noord-Holland, Netherlands
Centrum Onkologii Instytut im.Marii Sklodowskiej Curie-Oddzial w Gliwicach, Gliwice, , Poland
Institutul National de Endocrinologie "C. I. Parhon", Bucharest, , Romania
Chulalongkorn University, Pathum Wan, Krung Thep Maha Nakhon, Thailand
Contact Details
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