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Endometrial CarcinomaPhase 2NCT04716686

Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma

A Phase 2 study testing Niraparib in people with Endometrial Carcinoma and Serous Carcinoma, run by Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Endometrial Serous carcinoma (ESC) has similar molecular characteristics to high-grade serous ovarian carcinoma (HGSOC) and basal cell-like breast cancer, such as similar Chromosomal instability, somatic copy number variation profiles and somatic mutations. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Carcinoma, Serous Carcinoma
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteChina
Study dates
1 Jun 2021to 31 Dec 2026
Phase
Phase 2
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

  • Women aged 18 or above
  • Histological confirmation of serous endometrial cancer or other types of endometrial cancer
  • FIGO stage III-IV
  • ESC Patients have received at least 6 cycles of first-line platinum containing chemotherapy after surgery and achieved CR, PR or SD; ESC patients have received platinum containing chemotherapy after the first relapse and achieved CR, PR or SD; these two types of patients are enrolled in cohort 1 and receive niraparib alone as maintenance therapy within 12 weeks after the last chemotherapy treatment.
  • ESC Patients have received >2 lines of platinum containing chemotherapy and relapsed; patients with other types of endometrial cancer have received >2 lines of platinum containing chemotherapy and have BRCA mutation or be defined as HRD positive; these 2 types of patients are enrolled in cohort 2 and receive niraparib monotherapy.
  • Radiotherapy or endocrine therapy history is allowed
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  • Cohort 1 life expectancy> 6 months; Cohort 2 life expectancy> 4 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Patients agreed to provide blood samples for testing BRCA status and HRR mutations.
  • Patients agreed to provide formalin-fixed and paraffin-embedded tumor tissue samples for the detection of homologous recombination repair related genes (optional)
  • Laboratory criteria are as follows:
  • Neutrophil count ≥1500/µL;Platelets ≥100,000/µL;Hemoglobin ≥10g/dL;Serum creatinine ≤1.5 times of the upper limit, or creatinine clearance ≥60mL/min;Total bilirubin ≤1.5 times of the upper limit or direct bilirubin ≤1.0 times of the upper limit;AST and ALT ≤2.5 times of the upper limit, and must be ≤5 times of the upper limit of when liver metastasis exists.
  • Patients of reproductive potential must have a negative urinary or serum pregnancy test when done and promise to take effective contraceptive measuresduring the period of the study; Or without potential fertility, defined as:
  • Women who have undergone contraceptive operation(hysterectomy, bilateral oophorectomy or bilateral salpingectomy), or
  • over 60 years old, or≥40 and <60 years of age, menopause for more than 12 months, and follicle-stimulating hormone test results are within the reference range of research institutions after menopause
  • Willingness to sign a written informed consent document and follow the plan
  • Any previous toxic and side effects of chemotherapy have recovered to ≤ CTCAE level 1 or baseline level, except for sensory neuropathy or hair loss with stable symptoms ≤ CTCAE level 2

Who cannot join

  • Allergic to active or inactive ingredients of ZL-2306 (nirapali) or drugs with similar chemical structure to ZL-2306 (nirapali)
  • Stage Ia(on invasion to myometrium)
  • Symptomatic, uncontrollable brain metastases or pial metastases(No imaging scan is required); patients with spinal cord compression can still be considered for enrollment if they have received targeted therapy and have evidence of clinically SD for at least 28 days (patients with controlled central nervous system metastasis must have received radiotherapy or chemotherapy at least 1 month before and with no new symptoms related to central nervous system lesions or symptoms suggesting disease progression)
  • Received surgery within 3 weeks before the start of the study, or any surgical effects that have not recovered.
  • Received palliative radiotherapy with >20% bone marrow 1 week before enrollment
  • Suffered from other aggressive cancers (except for fully treated basal or squamous cell skin cancer) within 2 years before enrollment
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  • Previously or currently diagnosed as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  • Suffer from serious or uncontrollable diseases, including but not limited to:
  • Uncontrollable nausea and vomiting, inability to swallow drugs, any gastrointestinal diseases that may interfere with drug absorption and metabolism
  • Active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.
  • Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders
  • Immune deficiency (except for splenectomy)
  • Any past or current disease, treatment or laboratory abnormality that may interfere with the results of the study, or be defined as not suitable for this study
  • Receive platelet or red blood cell transfusion within 4 weeks before the start of the study.
  • Pregnant or breastfeeding, or expect to become pregnant during the study.
  • Have received any PARP inhibitor treatment previously.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qing Zhang contact

86-18560085996

qiluqingzhang@sdu.edu.cn

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Xi Zhang, 86-18560082013, happylittlebrook@163.com

    Recruiting

Other trials in China

About this study

Official title: Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma: A Multi-center, Open-label, Prospective Clinical Study

Endometrial Serous carcinoma (ESC) has similar molecular characteristics to high-grade serous ovarian carcinoma (HGSOC) and basal cell-like breast cancer, such as similar Chromosomal instability, somatic copy number variation profiles and somatic mutations. The clinical treatment of ESC also refers to the treatment model of HGSOC. The PARP inhibitor niraparib used in this study, which was approved by FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy on March 27, 2017.

The homologous recombination related gene mutations in total endometrial cancer accounted for 22%. Homologous Recombination Repair Defect (HRD) +ARID1A accounted for 48%, and 53% of endometrial cancer cell lines were sensitive to PARP inhibitors. The incidence of HRD in endometrial cancer with high copy number (the pathological type is mainly ESC) is 50%, suggesting potential clinical applications of PARP inhibitors for the treatment of ESC.

Being tested
Niraparib
Keywords
Endometrial Serous carcinoma, maintenance therapy, recurrent therapy, PARP inhibitor
Medical subject headings
Endometrial Neoplasms, Cystadenocarcinoma, Serous

What participants receive

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

  • NiraparibDrug

    Patients received oral niraparib 200/300 mg QD and every cycle (28 days) thereafter until disease progression.

Study groups in NCT04716686
Study groupRoleWhat they receive
Niraparib as maintenance therapy for Endometrial Serous CarcinomaExperimentalFor patients with baseline weight ≥ 77 kg and baseline platelets ≥ 150000/uL, a starting dose of 300 mg QD will be given; other patients will be given a starting dose of 200 mg QD. One treatment cycle is 28 days; follow-up and evaluation will be conducted every 2 cycles until the disease progression or patients cannot tolerate.
Receives: Drug: Niraparib
Niraparib as recurrent therapy for Endometrial CarcinomaExperimentalFor patients with baseline weight ≥ 77 kg and baseline platelets ≥ 150000/uL, a starting dose of 300 mg QD will be given; other patients will be given a starting dose of 200 mg QD. One treatment cycle is 28 days; follow-up and evaluation will be conducted every 2 cycles until the disease progression or patients cannot tolerate.
Receives: Drug: Niraparib

What is being measured

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

  1. PFS%（1 year）

    for maintenance therapy arm

    Measured: assessed up to 12 months

  2. Objective Response Rate (ORR)

    for maintenance therapy arm

    Measured: assessed up to 30months]

Secondary outcomes (4)

  1. PFS%（2 year）

    for maintenance therapy am

    Measured: assessed up to 24 months

  2. Overall Survival (OS)

    for maintenance therapy am

    Measured: assessed up to 30 months

  3. Median PFS

    for recurrent therapy am

    Measured: assessed up to 30 months

  4. TEAEs

    for maintain and recurrent therapy arms

    Measured: assessed up to 30 months

Timeline

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

  1. First posted20 Jan 2021
  2. Study start1 Jun 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716686
Sponsor's protocol ID
ZL-2306-914
Status last verified
Jan 2024
First submitted
9 Dec 2020
Last updated
5 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Yoon JH, Yoo SC, Kim WY, Chang SJ, Chang KH, Ryu HS. Para-aortic lymphadenectomy in the management of preoperative grade 1 endometrial cancer confined to the uterine corpus. Ann Surg Oncol. 2010 Dec;17(12):3234-40. doi: 10.1245/s10434-010-1199-5. Epub 2010 Jun 29.

    PubMed 20585865

  • Kaelin WG Jr. The concept of synthetic lethality in the context of anticancer therapy. Nat Rev Cancer. 2005 Sep;5(9):689-98. doi: 10.1038/nrc1691.

    PubMed 16110319

  • Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31.

    PubMed 24882434

  • Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmana J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Steiner M, Loman N, Bowen K, Fielding A, Domchek SM. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015 Jan 20;33(3):244-50. doi: 10.1200/JCO.2014.56.2728. Epub 2014 Nov 3.

    PubMed 25366685

  • Watkins JA, Irshad S, Grigoriadis A, Tutt AN. Genomic scars as biomarkers of homologous recombination deficiency and drug response in breast and ovarian cancers. Breast Cancer Res. 2014 Jun 3;16(3):211. doi: 10.1186/bcr3670.

    PubMed 25093514

  • Cancer Genome Atlas Research Network; Kandoth C, Schultz N, Cherniack AD, Akbani R, Liu Y, Shen H, Robertson AG, Pashtan I, Shen R, Benz CC, Yau C, Laird PW, Ding L, Zhang W, Mills GB, Kucherlapati R, Mardis ER, Levine DA. Integrated genomic characterization of endometrial carcinoma. Nature. 2013 May 2;497(7447):67-73. doi: 10.1038/nature12113.

    PubMed 23636398

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Endometrial Carcinoma and Serous Carcinoma, run by Shandong University at 1 site 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 17 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Qing Zhang (86-18560085996, qiluqingzhang@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS%（1 year） (time frame: assessed up to 12 months). The study lists 2 primary outcomes in all. 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 NCT04716686, which also lists 7 linked publications.

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 5 Jan 2024.

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