New pill may keep ovarian cancer at bay after chemo
NCT ID NCT04169997
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 study tests a drug called IMP4297 (a PARP inhibitor) as a maintenance treatment for people with advanced ovarian cancer (stage III or IV) who have finished their first round of chemotherapy. The goal is to see if taking this drug daily can delay the cancer from coming back. About 404 participants are randomly assigned to receive either IMP4297 or a placebo in a 2:1 ratio. The study is double-blind, meaning neither participants nor doctors know who gets the real drug.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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404 people
The number who actually took part.
- Started
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Dec 2019
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects have the ability to read, communicate effectively with the investigator and sign the ICF in writing. Subjects have to provide ICF prior to any study-specified procedures * Subjects must be ≥ 18 years of age * Newly diagnosed, histologically confirmed FIGO stage III-IV high grade serous, high grade endometrioid or BRCA mutant other histological types of epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (according to local pathological diagnosis) (with concrete staging criteria of FIGO provided in Appendix 7) * Subjects who have completed first-line platinum-based (carboplatin or cisplatin) chemotherapy (intravenous or intraperitoneal) prior to randomization * The test results of CA125 before treatment must meet the following specific criteria: * If the first test value is ≤upper limit of normal (ULN), the subject can be randomized without second sampling * If the first test value is \>ULN, a second assessment must be performed at least 7 days after the first. If the value of the subject's second assessment is ≥15% higher than that of the first, the subject is not eligible for inclusion * Subjects must have normal organ and bone marrow function, as defined below, within 28 days prior to the first dose of investigational drug (corrective treatment with blood products ≤28 days prior to the first dose of investigational drug, such as blood transfusion, is not allowed) * Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1 * Subjects must have a life expectancy ≥16 weeks Exclusion Criteria: * Participation in the planning and/or conduct of the study (applicable to sponsor staff and/or site staff) -BRCA mutation status is unclear * Subjects with early disease (FIGO stage I or II) -Subjects with tumor assessment of SD or PD after first-line chemotherapy * More than one cytoreductive surgery prior to study randomization. (Subjects with tumor considered unresectable in diagnosis and with biopsy or oophorectomy only, followed by continued chemotherapy and intermittent cytoreductive surgery can be enrolled in the study) * Subjects with previously diagnosed with early stage ovarian, fallopian tube, or primary peritoneal cancer followed by treatment * Subjects with previously received chemotherapy for any abdominal or pelvic tumor, including treatment of previously diagnosed early stage ovarian, fallopian tube, or primary peritoneal cancer -Subjects with ascites drawn during the last two chemotherapy cycles prior to study enrollment * Have been randomized in this study * Have participated in another investigational drug trial during chemotherapy prior to randomization * History of other malignancies within the past 5 years, except for the following: adequately treated thyroid cancer, non-melanoma skin cancer, effectively treated carcinoma in situ of the cervix, Stage I ductal carcinoma in situ (DCIS), stage I grade 1 endometrial cancer or other solid tumors, including lymphomas (without bone marrow involvement) that have been treated effectively and without evidence of disease for more than 5 years * Classification II or above severe congestive heart failure assessed by New York Heart Association (NYHA); history of myocardial infarction or unstable angina within 6 months before treatment; history of stroke or transient ischemic attack within 6 months before treatment * Any systemic chemotherapy or radiotherapy (except for palliative reasons) within 4 weeks (or longer, depending on the characteristics of the drug used) prior to the first dose of investigational drug * Subjects who have received strong CYP3A4 inhibitors or strong CYP3A4 inducers before the first dose of the investigational drug (≥ 5 half-lives of washout period from the first dose of the investigational drug can be enrolled) and need to continue to receive these drugs during the study * Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03, except alopecia * Subjects with myelodysplastic Syndrome (MDS) /Acute Myeloid (AML) Leukemia * Have active or untreated metastases in central nervous system; subjects with treated brain metastases can be enrolled if the following criteria is met * Have no imaging progression ≥ 4 weeks after the end of treatment (EOT); * The treatment completed ≥ 28 days prior to the first dose of investigational drug; * Treatment with systemic corticosteroids (\> 10 mg/day prednisone or equivalent) is not required ≤ 14 days prior to the first dose of investigational drug * Have received drugs targeting poly-ADP-ribose polymerase (PARP) * Have clinically significant active infection at the discretion of the investigator * History of clinically significant liver disease at the discretion of the investigator, 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 * Have infection of human immunodeficiency virus (HIV) * Subjects who are unable to swallow oral preparations and with gastrointestinal disorders, so the absorption of the investigational drug may be interfered * Nursing women * Subjects with known hypersensitivity to the investigational drug or its excipients * Have had major surgery within 4 weeks prior to the first dose of investigational drug -Subjects, at the discretion of the investigator, with poor compliance or with any factors unsuitable for participation in this trial; subjects, at the discretion of the investigator, to be unsuitable for participation in this study due to any clinical or laboratory abnormality
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
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Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, randomized, open-label phase III study of IBI354 versus Investigator's choice of chemotherapy in patients with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer
- Operationalising multifactorial ovarian cancer risk assessment using the CanRisk tool versus standard practices.
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- Blood vessel cells in a simple blood test may predict ovarian cancer therapy success
- Can a radioactive antibody light up hidden tumors on PET scans?