Spots Global Cancer Trial Database for Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
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Trial Identification
Brief Title: Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
Official Title: A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study.
Study ID: NCT04285086
Conditions
Study Description
Brief Summary: This is a Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of P1101 compared with ANA after 12 months of treatment as second-line therapy for subjects with ET who have had a suboptimal or failed response to HU.
Detailed Description: PharmaEssentia Corporation is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of ET. Available clinical data and experience with P1101 in PV shows that the compound, with proper dose modifications, is effective in controlling disease in a significant proportion of subjects with ET. Further, its increased serum half-life presents distinct advantages for ET treatment over that of standard IFN-α and other available PEG IFN-α therapy. This pivotal Phase 3 study will establish the efficacy and safety of P1101 in ET subjects. In core study phase, the enrolled subjects will be randomized into two arms, the test arm is P1101, the control arm is ANA. The overall duration for each eligible patient is 14 months, including screening (1 month), treatment (12 months) and follow-up (1 month) period. Efficacy evaluations, safety assessments, and PK and immunogenicity evaluations of P1101 will be performed. Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling, EQ-5D-3L, and MPN-SAF TSS completion. Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs. Subjects who completed the end of treatment (EoT) and safety follow-up (EoS) visits of the SURPASS ET study and may benefit from P1101 therapy have the opportunity to receive P1101 treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Washington University School of Medicine - Division of Oncology, Saint Louis, Missouri, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah, Salt Lake City, Utah, United States
St. Paul's Hospital, Vancouver, British Columbia, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Jewish General Hospital, Montréal, Quebec, Canada
Peking Union Medical College Hospital, Beijing, Beijing, China
Peking University People's Hospital, Beijing, Beijing, China
The First Affiliated Hospital, Chongqing Medical University, Chongqing, Chongqing, China
NanFang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technolog, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Ruijin Hospital affiliated to Shanghai Jiao Tong University school of Medicine, Shanghai, Shanghai, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
The Second Hospital of Tianjin Medical University, Tianjin, Tianjin, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Queen Mary Hospital, Hong Kong, , Hong Kong
Ehime University Hospital, Toon, Ehime, Japan
Kitasato University Hospital, Sagamihara, Kanagawa, Japan
Mie University Hospital, Tsu, Mie, Japan
University of Miyazaki Hospital, Miyazaki City, Miyazaki, Japan
Kansai Medical University Hospital, Hirakata, Osaka, Japan
Kindai University Hospital, Osakasayama, Osaka, Japan
Osaka University Hospital, Suita, Osaka, Japan
Juntendo University Shizuoka Hospital, Izunokuni, Shizuoka, Japan
Juntendo University Hospital, Bunkyo City, Tokyo, Japan
Nippon Medical School Hospital, Bunkyo City, Tokyo, Japan
NTT Medical Center Tokyo, Shinagawa City, Tokyo, Japan
Tokyo Medical University Hospital, Shinjuku City, Tokyo, Japan
University of Yamanashi Hospital, Chuo, Yamanashi, Japan
Daegu Catholic University Hospital, Daegu, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
SoonChunHyang University Seoul Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
National University Hospital, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Chia-Yi Christian Hospital, Chiayi City, Chiayi County, Taiwan
Chiayi Chang Gung Memorial Hospital, Chiayi City, Chiayi County, Taiwan
Hualien Tzu Chi Hospital, Hualien City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital, Kaohsiung City, , Taiwan
E-Da Cancer Hospital, Kaohsiung City, , Taiwan
E-Da Hospital, Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital, New Taipei City, , Taiwan
China Medical University Hospital, Taichung City, , Taiwan
National Cheng Kung University Hospital, Tainan City, , Taiwan
Tainan Municipal An-Nan Hospital, Tainan City, , Taiwan
Chi Mei Medical Center, Tainan City, , Taiwan
Chi-Mei Hospital - Liouying Branch, Tainan City, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Mackay Memorial Hospital, Taipei City, , Taiwan
Shin Kong Wu Ho-Su Memorial Hospital, Taipei City, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
Tri-Service General Hospital, Taipei City, , Taiwan
Taipei Municipal Wan Fang Hospital, Taipei City, , Taiwan
Linkou Chang Gung Memorial Hospital, Taoyuan City, , Taiwan
Contact Details
Name: Toshiaki Sato, MD/PhD
Affiliation: PharmaEssentia Japan K.K.
Role: STUDY_DIRECTOR
Name: Craig Zimmerman, PhD
Affiliation: PharmaEssentia USA Corp.
Role: STUDY_DIRECTOR
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