Spots Global Cancer Trial Database for IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
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Trial Identification
Brief Title: IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
Official Title: A Phase Ib/II, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
Study ID: NCT04434482
Interventions
Study Description
Brief Summary: This is an open-label, multi-center, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, PK characteristics and anti-tumor activity of PARP inhibitor IMP4297 and temozolomide combination therapy in patients with advanced solid tumors and with ES-SCLC who develops disease progression after 1L platinum-based regimen.
Detailed Description: This study will be conducted in two parts. Part I of the study will be dose escalation evaluation to determine the MTD and/or recommended phase 2 dose（RP2D） of IMP4297 in combination with temozolomide. Part II of the study will be conducted in two expansion cohorts (sensitive ES-SCLC cohort and resistant ES-SCLC cohort) to further evaluate the anti-tumor activity, safety and tolerability of this regimen in ES-SCLC patients.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GenHarp Clinical Solutions, Evergreen Park, Illinois, United States
Gabrail Cancer Researh Center, Canton, Ohio, United States
Mark H. Zangmeister Center, Columbus, Ohio, United States
Sarah Cannon Research Institute - Tennessee Oncology, Tennessee, Tennessee, United States
Border Medical Oncology, Albury, New South Wales, Australia
Blacktown Hospital, Blacktown, New South Wales, Australia
Orange Hospital, Orange, New South Wales, Australia
Peninsula Health Frankston Hospital, Frankston, Victoria, Australia
Beijing Cancer Hospital, Beijing, , China
Jilin Cancer Hospital, Jilin, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Hubei Cancer Hospital, Wuhan, , China
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
The Catholic university of Korea, st. Vincent's Hospital, Gyeonggi-do, , Korea, Republic of
Yonsei university health system, Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi Mei Medical Center, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation Linko, Taoyuan, , Taiwan
Contact Details
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