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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169997
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Impact Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: IMP4927 Drug: Placebos Phase 3

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 of Subjects with International Federation of Gynecology and Obstetrics (FIGO) Stage III-IV Ovarian Cancer. Subjects with newly diagnosed III/IV high-grade serous ovarian carcinoma (HGSOC) or other histological types of ovarian cancer, fallopian tube cancer or primary peritoneal cancer carrying breast cancer susceptibility gene (BRCA) mutation 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 24, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: IMP4297
The starting dose is 100mg QD
Drug: IMP4927
IMP4297 tablet.The starting dose from 100mg QD

Placebo Comparator: Placebos
The starting dose is 100mg QD
Drug: Placebos
Placebos tablet.The starting dose from 100mg QD




Primary Outcome Measures :
  1. PFS [ Time Frame: Approximately 42 months since the first subject enrolled ]
    BICR-assessed progression-free survival (PFS)


Secondary Outcome Measures :
  1. CFI [ Time Frame: Approximately 42 months since the first subject enrolled ]
    chemotherapy- free interval assessed by Investigators

  2. PFS2 [ Time Frame: Approximately 42 months since the first subject enrolled ]
    progression-free survival 2 (PFS2) assessed by Investigators

  3. TFST [ Time Frame: Approximately 42 months since the first subject enrolled ]
    Time to first subsequent anti-tumor treatment (TFST)

  4. TDT [ Time Frame: Approximately 42 months since the first subject enrolled ]
    time from randomization to study treatment discontinuation or death (TDT)

  5. os [ Time Frame: Approximately 42 months since the first subject enrolled ]
    the time from the date of randomization to the date of death caused by any reason



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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 HGSOC or other histological types of ovarian cancer, fallopian tube cancer or primary peritoneal cancer with BRCA mutation (according to local pathological diagnosis)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169997


Contacts
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Contact: Calvin mei 15021115582 ext 15021115582 chongzi.mei@impacttherapeutics.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guanzhou, Guangdong, China
Contact: Jihong Liu         
Principal Investigator: Jihong Liu         
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China
Contact: Xiaohu Wu         
Principal Investigator: Xiaohua Wu         
Sponsors and Collaborators
Impact Therapeutics, Inc.

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Responsible Party: Impact Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04169997    
Other Study ID Numbers: IMP4297-301
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type