AzTrials
AzTrials

Platinum-sensitive Relapsed Ovarian CancerPhase 3NCT03705156

Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient

A Phase 3 study testing ZL-2306(nirapairb) in people with Platinum-sensitive Relapsed Ovarian Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 27 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase III clinical study evaluating the efficacy and safety of ZL-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer (collectively… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ZL-2306(nirapairb)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
265 participants
Where
27 sitesChina
Study dates
8 Jun 2017to 24 Aug 2024
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

  • Aged 18 years or older female.
  • High-grade serous or dominantly high-grade serous ovarian cancer
  • The subject shall have received two lines of platinum-containing chemotherapy, complete response [CR] or partial response [PR] after first-line platinum-containing chemotherapy, and after received at least 4 cycles of platinum-containing (must be carboplatin or cisplatin or nedaplatin) in second-line platinum-containing chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Who cannot join

  • Patients who have undergone ascites drainage with the last two cycles of the last chemotherapy regimen prior to enrollment.
  • Symptomatic brain metastases or leptomeningeal metastases that have not been controlled.
  • Patients who have been diagnosed previously or currently with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • Beijing Cancer Hospital

    Beijing

  • Cancer hospital Chinese academy of medical science

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University People's hospital

    Beijing

  • The first Bethune 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

  • Cancer center of Guangzhou medical university

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Woman's hospital School of medicine Zhejiang University

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin Medical university cancer hospital

    Harbin, Heilongjiang

  • the first affiliated hospital of of Harbin medical university

    Harbin, Heilongjiang

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Yunnan Cancer Hospital

    Kunming, Yunnan

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

  • Tianjin Tumour Hospital

    Tianjin

  • Affiliate Cancer Hospital Xinjiang Medical University

    Ürümqi, Xinjiang

  • Hubei Cancer Hospital

    Wuhan, Hubei

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

    Wuhan, Hunan

  • Shaanxi Cancer Hospital

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi

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 Platinum-sensitive Relapsed Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer (Collectively Referred to as Ovarian Cancer)

This is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase III clinical study evaluating the efficacy and safety of ZL-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer (collectively referred to as relapsed ovarian cancer).The evaluation will be divided into two stages: Stage I will be conducted in all patients, and if the predetermined statistically significant difference is not reached, the trial will continue to extend to Stage II during which evaluation will be performed in gBRCA mutation-positive ovarian cancer patients.

Being tested
ZL-2306(nirapairb), Placebos

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 300 mg or 200 mg based on patient's body weight.

  • PlacebosDrug

    The starting dose is the matched dose of placebo (3 capsules or 2 capsules).

Study groups in NCT03705156
Study groupRoleWhat they receive
ZL-2306ExperimentalThe starting dose is 300 mg or 200 mg based on patient's body weight.
Receives: Drug: ZL-2306(nirapairb)
PlaceboPlacebo comparatorThe starting dose is the matched dose of placebo (3 capsules or 2 capsules).
Receives: Drug: Placebos

What is being measured

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

  1. Progression-free survival (PFS)

    It is defined as the time from randomization to progressive disease or death due to various causes, whichever occurs first. Progressive disease will be determined by the Independent Central Imaging Review according to standard RECIST 1.1.

    Measured: 35 months

Secondary outcomes (3)

  1. Chemotherapy-free interval (CFI)

    It refers to the time from the last platinum-containing treatment to the start of the next anti-cancer treatment (excluding maintenance treatment);

    Measured: 35 months

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

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

    Measured: 35 months

  3. Overall survival (OS)

    It refers to the time from the date of randomization to death for any cause.

    Measured: 35 months

Timeline

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

  1. First posted15 Oct 2018
  2. Study start8 Jun 2017
  3. Primary completion1 Feb 2020
  4. Study completion24 Aug 2024 (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
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03705156
Sponsor's protocol ID
ZL-2306-001
Status last verified
Apr 2023
First submitted
19 Sep 2018
Last updated
13 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu X, Zhu J, Yin R, Yang J, Liu J, Wang J, Wu L, Liu Z, Gao Y, Wang D, Lou G, Yang H, Zhou Q, Kong B, Huang Y, Chen L, Li G, An R, Wang K, Zhang Y, Yan X, Lu X, Lu W, Hao M, Wang L, Cui H, Chen Q, Abulizi G, Huang X, Tian X, Wen H, Huang Z, Dong J, Zhang C, Hou J, Mirza MR. Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial. EClinicalMedicine. 2024 May 7;72:102629. doi: 10.1016/j.eclinm.2024.102629. eCollection 2024 Jun.

    PubMed 38745967

  • Wu XH, Zhu JQ, Yin RT, Yang JX, Liu JH, Wang J, Wu LY, Liu ZL, Gao YN, Wang DB, Lou G, Yang HY, Zhou Q, Kong BH, Huang Y, Chen LP, Li GL, An RF, Wang K, Zhang Y, Yan XJ, Lu X, Lu WG, Hao M, Wang L, Cui H, Chen QH, Abulizi G, Huang XH, Tian XF, Wen H, Zhang C, Hou JM, Mirza MR. Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA): a randomized, double-blind, placebo-controlled phase III trial☆. Ann Oncol. 2021 Apr;32(4):512-521. doi: 10.1016/j.annonc.2020.12.018. Epub 2021 Jan 14.

    PubMed 33453391

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZL-2306(nirapairb) in people with Platinum-sensitive Relapsed Ovarian Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 27 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 4 inclusion and 3 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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?

Progression-free survival (PFS) (time frame: 35 months). 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 NCT03705156, which also lists 2 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 13 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in