A phase II, multi-center, open-label, single-arm, non-randomized study to evaluate the efficacy, safety and tolerability of IMP4297 capsules in subjects with germline and/or somatic BRCA1/2 mutated advanced ovarian cancer in china
A total of 100 subjects with germline and/or somatic BRCA1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety, tolerability and PK profile of IMP4297. The primary objective is to assess ORR in subjects with germline and/or somatic BRCA1/2 mutated advanced ovarian cancer with at least 2 prior lines of standard systemic therapy treated with IMP4297 capsules by independent imaging according to RECIST v1.1. Subjects will be treated until there is evidence of disease progression or any other discontinuation criterion is met. Best supportive care will be provided to all subjects and will be decided by investigators if there are no other specific restrictions within the protocol. Four to seven blood samples (approximately 2 mL/sample) are planned to be collected for each enrolled subject for the popPK and/or dose-response evaluation. Sample collection visits are planned on Cycle (C) 1 Day (D) 1, C1D15, C2D1, C3D1 and C4D1. The actual administration time, dose and blood collection time should be accurately recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
IMP4297 100mg PO QD
Xiaohua.Wu
Shanghai, China
ORR
Disease response as determined by Overall Response Rate per RECIST Version 1.1
Time frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months
DOR
Disease response as determined by Duration of Response per RECIST Version 1.1
Time frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months
FPS
Disease response as determined by Progression Free Survival per RECIST Version 1.1
Time frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months
DCR
Disease response as determined by Disease Control Rate per RECIST Version 1.1
Time frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months
CBR
Disease response as determined by Clinical Benefit Rate per RECIST Version 1.1
Time frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months
OS
Disease response as determined by overall survival
Time frame: From enroll until subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months
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Incidence of Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events assessed by the investigator according to CTCAE 4.03
Time frame: from the day of first enrolled of study drugs up to 30 days after the last administration