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Ovarian CancerPhase 3FLAMESNCT04169997

A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

A Phase 3 study testing IMP4927 in people with Ovarian Cancer, run by Impact Therapeutics, Inc. at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

IMP4297 is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of IMP4297 for Maintenance Treatment Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
IMP4927
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
404 participants
Where
2 sitesChina
Study dates
24 Dec 2019to 30 Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sun Yat-sen University Cancer Center

    Guanzhou, Guangdong

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase III Study to Evaluate the Efficacy and Safety of IMP4297 Following 1st Line Chemotherapy in the Monotherapy Maintenance Treatment of Subjects With Ovarian Cancer

IMP4297 is a PARP inhibitor. This is a 2:1 randomized, double-blind, placebo-controlled study conducted in patients with advanced (FIGO Stage III or IV) ovarian cancer to evaluate Efficacy and Safety of IMP4297 for Maintenance Treatment

Read the detailed description

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of IMP4297 Following First-Line Platinum-based Chemotherapy in the Monotherapy Maintenance Treatment . The Subjects with newly diagnosed, histologically confirmed FIGO stage lll-IV high grade serous, high grade endometrioid or BRCA mutant other histological types of epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have had a complete/partial response (CR/PR) after first-line platinum-based therapy will be randomly assigned to IMP4297 or placebo at a 2:1 ratio.

Conditions
Ovarian Cancer
Being tested
IMP4927, Placebos
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMP4927Drug

    IMP4297 tablet.The starting dose from 100mg QD

  • PlacebosDrug

    Placebos tablet.The starting dose from 100mg QD

Study groups in NCT04169997
Study groupRoleWhat they receive
IMP4297ExperimentalThe starting dose is 100mg QD
Receives: Drug: IMP4927
PlacebosPlacebo comparatorThe starting dose is 100mg QD
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    BICR-assessed progression-free survival (PFS)

    Measured: Approximately 42 months since the first subject enrolled

Secondary outcomes (5)

  1. CFI

    chemotherapy- free interval assessed by Investigators

    Measured: Approximately 42 months since the first subject enrolled

  2. PFS2

    progression-free survival 2 (PFS2) assessed by Investigators

    Measured: Approximately 42 months since the first subject enrolled

  3. TFST

    Time to first subsequent anti-tumor treatment (TFST)

    Measured: Approximately 42 months since the first subject enrolled

  4. TDT

    time from randomization to study treatment discontinuation or death (TDT)

    Measured: Approximately 42 months since the first subject enrolled

  5. os

    the time from the date of randomization to the date of death caused by any reason

    Measured: Approximately 42 months since the first subject enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2019
  2. Study start24 Dec 2019
  3. Primary completion16 Mar 2023
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04169997
Sponsor's protocol ID
IMP4297-301
Acronym
FLAMES
Status last verified
Jan 2026
First submitted
17 Nov 2019
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu X, Liu J, Wang J, Wang L, Lin Z, Wang X, Zhu J, Kong B, Fei J, Tang Y, Xia B, Liang Z, Wang K, Huang Y, Zheng H, Lin A, Jiang K, Wang W, Wang X, Lou G, Pan H, Yao S, Li G, Hao M, Cai Y, Chen X, Yang Z, Chen Y, Wen H, Qu P, Xu C, Hsieh CY; FLAMES Investigators. Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial. Nat Med. 2024 Jun;30(6):1612-1621. doi: 10.1038/s41591-024-03003-9. Epub 2024 May 15.

    PubMed 38750351

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IMP4927 in people with Ovarian Cancer, run by Impact Therapeutics, Inc. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: Approximately 42 months since the first subject enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04169997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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