Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer (NCT04089189) | Clinical Trial Compass
CompletedPhase 2
Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer
China93 participantsStarted 2019-10-28
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects have to sign ICF prior to study-related procedures.
. Female subjects ≥ 18 years of age with histologically or cytologically confirmed advanced non-mucinous ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer;
. Germline and/or somatic BRCA1/2 mutation confirmed by central laboratory;
. Disease relapse or progression after no less than 2 prior lines of platinum-based chemotherapy
. No disease relapse or progression (based on clinical, CA125 or imaging) within 6 calendar months after the last platinum-containing regimen;
. At least one measurable lesion confirmed by independent central imaging according to the criteria of RECIST v1.1;
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1 (refer to Appendix 1);
. Expected survival time ≥ 12 weeks;
Exclusion criteria
. Inadequate hematopoiesis or organ function (corrective treatment with blood products ≤ 14 days prior to the first dose of investigational drug, e.g. transfusion, etc., is not allowed):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ORR
Timeframe: 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
. Have a history of radiation therapy \< 4 weeks prior to the first dose of investigational drug, or chemotherapy, biological therapy, endocrine therapy or small molecule targeted therapy before the first dose of investigational drug (subject whose washout period ≥ 5 half-lives from the first dose of investigational drug can be enrolled);
. Have received strong CYP3A4 inhibitors or strong CYP3A4 inducers prior to the first dose of investigational drug (washout period from the first dose of investigational drug ≥ 5 half-lives is allowed) or require continued treatment with these drugs during the study (as described in Section 6.9.2 of the protocol; refer to Appendix 2 for common CYP3A4 strong inhibitors or CYP3A4 strong inducers)
. Have not recovered to NCI CTCAE v4.03 ≤ grade 1 from the toxicity of previous anti-tumor treatment, except alopecia;
. Have had treatment with drugs targeting poly-ADP-ribose polymerase (PARP);
. Clinically significant active infection;
. History of clinically significant liver disease, including active viral or other hepatitis, history of alcohol abuse or cirrhosis; except for subjects with previous viral hepatitis confirmed to be inactive by polymerase chain reaction (PCR) assay;