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

NCT04169997 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: IMP4297-301
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  BICR-assessed progression-free survival (PFS)

  Approximately 42 months since the first subject enrolled

Secondary Outcomes (5)

• CFI

  Approximately 42 months since the first subject enrolled

• PFS2

  Approximately 42 months since the first subject enrolled

• TFST

  Approximately 42 months since the first subject enrolled

• TDT

  Approximately 42 months since the first subject enrolled

• os

  Approximately 42 months since the first subject enrolled

Study Arms (2)

IMP4297

EXPERIMENTAL

The starting dose is 100mg QD

Drug: IMP4927

Placebos

PLACEBO COMPARATOR

The starting dose is 100mg QD

Drug: Placebos

Interventions

IMP4927 DRUG

IMP4297 tablet.The starting dose from 100mg QD

IMP4297

Placebos DRUG

Placebos tablet.The starting dose from 100mg QD

Placebos

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (2)

Sun Yat-sen University Cancer Center

Guanzhou, Guangdong, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 38750351 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Xiaohua wu

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 20, 2019
• Study Start: December 24, 2019
• Primary Completion: March 16, 2023
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)