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Ovarian CancerPhase 3NCT03709316

A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer

A Phase 3 study testing ZL-2306 (Nirapairb) in people with Ovarian Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 31 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Niraparib 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 ZL-2306 (Niraparib) 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?
ZL-2306 (Nirapairb)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
384 participants
Where
31 sitesChina
Study dates
30 Jun 2018to 30 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 1. The written informed consent form shall be signed before proceeding with any study-related procedure.
  • 2. The subject agrees to collection of blood samples for detection of gBRCA mutations (gBRCA mutation status must be known before randomization).
  • 3. The subject shall be a female, aged 18 years or older.
  • 4. Histologically confirmed high-grade serous/endometrioid or dominantly high-grade serous/endometrioid epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma (no histological restriction for patients carrying germline BRCA mutations).
  • Note: Patients who have received neoadjuvant chemotherapy can also be enrolled if their tumors after chemotherapy cannot be pathologically graded.
  • 5. FIGO staging is Stage III or IV.
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  • 6. Criteria for previous surgery (meeting any of these):
  • Inoperable Stage III or IV patients
  • Stage IV patients, regardless of postoperative residual lesion status
  • Stage III patients who have undergone primary tumor reductive surgery with postoperative residual lesion status of R1 (microscopic residual lesions) or R2 (macroscopic residual lesions)
  • Stage III or IV patients who have undergone intermittent tumor reductive surgery (patients who have used neoadjuvant therapy) regardless of postoperative residual lesion status
  • 7. Criteria for previous chemotherapy:
  • It is allowed to enroll patients who have received intraperitoneal chemotherapy
  • Patients have completed at least 6 cycles yet no more than 9 cycles of first-line platinum-containing chemotherapy (preferably carboplatin, but cisplatin is also acceptable)
  • Patients undergoing intermittent tumor reductive surgery should respectively receive at least 2 cycles of platinum-containing chemotherapy preoperatively and postoperatively, and receive a total of at least 6 cycles yet no more than 9 cycles of chemotherapy (preferably carboplatin, but cisplatin is also acceptable) preoperatively and postoperatively
  • Patients are assessed by the investigator to have achieved complete response (CR) or partial response (PR) after first-line platinum-containing chemotherapy, and the efficacy assessment should be performed after the end of at least 3 cycles of chemotherapy
  • CA-125 level must be within the normal range after the end of chemotherapy or has decreased by more than 90% during the course of first-line chemotherapy and remains so for at least 7 days (the elevation of CA-125 prior to enrollment shall not exceed 15% compared with the CA-125 level after the end of chemotherapy)
  • Patients must be randomized within 12 weeks since Day 1 of the last cycle of chemotherapy 8. Patients must be able to submit formalin-fixed, paraffin-embedded tumor tissue samples.
  • 9. ECOG physical condition score of the patient shall be 0 or 1.
  • 10. Organ function is in good condition, including:
  • Neutrophil count ≥1.5×109/L
  • Platelet count ≥100×109/L
  • Hemoglobin ≥100 g/L
  • Serum creatinine is not more than 1.5 times the normal upper limit, or creatinine clearance rate is not less than 60 mL/min (calculated with Cockcroft-Gault formula)
  • Total bilirubin is not more than 1.5 times the normal upper limit, or direct bilirubin is not more than 1.0 time the normal upper limit.
  • AST and ALT are not more than 2.5 times their normal upper limit, and with existence of hepatic metastasis, these values must not be more than 5 times their normal upper limit.
  • 11. Only the female patient who has been tested with pregnancy-negative result and had made a commitment to adopt effective contraption measures or to avoid sexual behavior from the start to the completion of the study and within 3 months after the last administration of study medication is eligible to be enrolled into the study. Or female patients without childbearing potential may be enrolled in the study, defined as follows:
  • A female who has undergone surgical birth control operation (e.g., hysterectomy, bilateral ovariectomy, or bilateral tubal resection); or
  • A female aged 60 years or older; or
  • A female, aged ≥40 years and <60 years, with a period of menolipsis for 12 months or longer, whose follicle-stimulating hormone test results are within the post-menopause reference range of the study institution.
  • 12. Patients must be able to take medication orally and have the ability to comply with the protocol.
  • 13. Any previous toxic and side effect of the patient has restored to CTCAE grade ≤1 or the baseline level, except for CTCAE grade ≤2 symptomatically stable sensory neuropathy or alopecia.

Who cannot join

  • 1. Patients diagnosed with mucinous, clear cell subtypes of epithelial ovarian cancer, carcinosarcoma, or undifferentiated ovarian cancer.
  • 2. Stage III patients who have undergone primary tumor reductive surgery with postoperative status of R0-complete resection (with no residual lesion).
  • 3. Patients who have undergone tumor reductive surgery more than twice.
  • 4. Patients who plan to or have used bevacizumab as maintenance therapy after first-line platinum-containing chemotherapy. If the patient received bevacizumab in platinum-containing chemotherapy but did not receive bevacizumab as maintenance therapy, and the last dose of bevacizumab was used ≥ 28 days before signing the master informed consent form, the patient can be enrolled.
  • 5. Patients who are known to be allergic to active or inactive ingredients of ZL-2306 (niraparib) or other drugs with similar chemical structures to ZL-2306 (niraparib).
  • 6. Patients who have previously been treated with PARP inhibitors (including niraparib).
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  • 7. Patients who have received other study drug treatment within 4 weeks prior to the first administration or < 5 elimination half-lives of the study drug (whichever is longer).
  • 8. Patients with ≥ grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy for more than 4 weeks.
  • 9. Patients with transfusion-dependent anemia or thrombocytopenia, including:
  • Patients who have received blood transfusion (platelet or red blood cell) within 2 weeks before the first dose
  • Patients who have received colony stimulating factor therapy (e.g., granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), or recombinant erythropoietin) within 2 weeks before the first dose
  • 10. Patients who have undergone ascites drainage within 4 weeks prior to enrollment.
  • 11. Brain metastases or leptomeningeal metastases that have not been treated or whose symptoms have not been controlled (e.g., new or worsening symptoms or signs, or the required dose of hormones is not yet stable). Note: It is not necessary to perform an imaging scan to confirm whether there is a brain metastasis or not; patients with spinal cord compression who have received symptomatic treatment and have evidence on clinical stable status of the disease for at least 28 days could still be considered as eligible for enrollment.
  • 12. Patients who have received a major surgery 3 weeks before the start of the study, or is subject to any surgical effect that has not yet been recovered after surgery.
  • 13. Patients who have received palliative radiotherapy for > 20% of bone marrow 3 weeks prior to enrollment.
  • 14. Patients suffered from invasive cancers other than ovarian cancer within 5 years prior to enrollment (except for treated carcinoma in situ of cervix, non-melanoma and ductal carcinoma in situ).
  • 15. Patients who have been diagnosed previously or currently with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • 16. Patients who have got other severe or uncontrollable diseases, including but not limited to:
  • Hardly controllable nausea and vomiting, inability to swallow the study drug, and any gastrointestinal disease that may interfere with the absorption and metabolism of the drug
  • Human immunodeficiency virus (HIV) infection, active hepatitis (hepatitis B, hepatitis C)
  • Uncontrolled ventricular arrhythmias, myocardial infarction that occurred within 3 months before enrollment
  • Uncontrollable grand mal epilepsy, unstable spinal cord compression, superior vena cava syndrome or other psychiatric disorders that may affect signing of the informed consent by the patient
  • Immunodeficiency (except for splenectomy), or other diseases which, as believed by investigators, could expose the patient to a high risk
  • 17. Patients who are pregnant or breastfeeding currently, or expect to plan for pregnancy in the course of the study treatment.
  • 18. The corrected QT interval (QTc) is more than 470 msec; if the patient has an extended QTc interval, but investigators find such a extension is caused by a cardiac pacemaker (without any other cardiac abnormality), it shall be necessary to determine whether the patient is eligible for enrollment or not based on the discussion with the study physician from the sponsor.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Beijing Cancer Hospital

    Beijing

  • Cancer Hospital of Chinese Academy of Medical Sciences

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University People's hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Xiangya Hospital Central South Hospital

    Changsha, Hunan

  • West China second university hospital

    Chengdu, Sichuan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • The first affiliated hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • Guizhou Cancer hospital

    Guiyang, Guizhou

  • Woman's hospital School of medicine Zhejiang University

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • Anhui Provincal Hospital

    Hefei, Anhui

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Yunnan Cancer Hospital

    Kunming, Yunnan

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

  • second hospital of Shanxi medical university

    Taiyuan, Shanxi

  • Tianjin Central Hospital of Gynecology Obstetrics

    Tianjin, Tianjin Municipality

  • Tianjin Tumour Hospital

    Tianjin

  • Affiliate Cancer Hospital Xinjiang Medical University

    Ürümqi, Xinjiang

  • the First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • Zhongnan hospital of wuhan university

    Wuhan, Hubei

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) for Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer) Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy

Niraparib 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 ZL-2306 (Niraparib) for Maintenance Treatment

Conditions
Ovarian Cancer
Being tested
ZL-2306 (Nirapairb), Placebo Comparator
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • ZL-2306 (Nirapairb)Drug

    The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

  • Placebo ComparatorDrug

    The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Study groups in NCT03709316
Study groupRoleWhat they receive
ZL-2306 (Nirapairb)ExperimentalThe starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Receives: Drug: ZL-2306 (Nirapairb)
PlaceboPlacebo comparatorThe starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Receives: Drug: Placebo Comparator

What is being measured

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

  1. BICR-assessed progression-free survival (PFS)

    the time from randomization to progressive disease or death due to various causes assessed by the BICR according to RECIST 1.1, whichever occurs first

    Measured: Approximately 36 months since the first subject enrolled

Secondary outcomes (3)

  1. Overall survival (OS)

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

    Measured: Approximately 36 months since the first subject enrolled

  2. Time to first subsequent anti-tumor treatment (TFST)

    the time from the date of randomization in the study to the date when the first subsequent anti-tumor treatment starts

    Measured: Approximately 36 months since the first subject enrolled

  3. PFS and OS assessed by BICR in patients with HRD (homologous recombination defects)

    positive patient population (including gBRCA-positive patients).

    Measured: Approximately 36 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 posted17 Oct 2018
  2. Study start30 Jun 2018
  3. Primary completion29 Jan 2022 (estimated)
  4. Study completion30 Dec 2023 (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
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03709316
Sponsor's protocol ID
ZL-2306-004
Status last verified
May 2021
First submitted
19 Sep 2018
Last updated
2 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li N, Zhu J, Yin R, Wang J, Pan L, Kong B, Zheng H, Liu J, Wu X, Wang L, Huang Y, Wang K, Zou D, Zhao H, Wang C, Lu W, Lin A, Lou G, Li G, Qu P, Yang H, Zhang Y, Cai H, Pan Y, Hao M, Liu Z, Cui H, Yang Y, Yao S, Zhen X, Hang W, Hou J, Wang J, Wu L. Treatment With Niraparib Maintenance Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Sep 1;9(9):1230-1237. doi: 10.1001/jamaoncol.2023.2283.

    PubMed 37440217

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZL-2306 (Nirapairb) in people with Ovarian Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 31 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 32 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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?

Results are not available in the source record.

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?

BICR-assessed progression-free survival (PFS) (time frame: Approximately 36 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 NCT03709316, 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 2 Jun 2021.

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