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Ovarian CancerPhase 2NCT04392102

A Study of Niraparib in Patients With Relapsed Ovarian Cancer

A Phase 2 study testing ZL-2306(Niraparib） in people with Ovarian Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. 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(Niraparib）
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
7 sitesChina
Study dates
4 Aug 2020to 11 Aug 2022
Phase
Phase 2
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. Patients must be female and at least 18 years of age
  • 2. Patients must provide written informed consent
  • 3. Patients must be gBRCA mutation or HRD positive
  • 4. Patients must have histologically diagnosed high-grade (Grade 2 or 3)serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease.
  • 5. Patients Must have completed 3 or 4 previous chemotherapy regimens.
  • 6. Patients must have measurable disease according to RECIST (v.1.1).
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  • 7. Patients must have an Eastern Cooperative Oncology Group(ECOG) performance status of 0 or1
  • 8. Patients must have adequate organ function, defined as follows: a. Absolute neutrophil count≥1500/ul b. Platelets ≥150000/ul c. Hemoglobin≥10g/dL d. Serum creatinine≤1.5X upper limit of normal (ULN)or calculated creatinine clearance≥60ml/min using the Cockcroft-Gault equation e. Total bilirubin≤1.5X ULN OR direct bilirubin≤1X ULN f. Aspartate aminotransferase and alanine aminotransferase≤2.5X ULN unless liver metastases are present, in which case they must be ≤5X ULN
  • 9. Patients must be either postmenopausal, free from menses for>12 months, surgically sterilized, or willing to use adequate contraception to prevent pregnancy or must agree to abstain from heterosexual activity throughout the study, starting with enrollment through 90 days after the last dose of study treatment
  • 10. Patients must have formalin-fixed, paraffin-embedded tumor samples available form primary or recurrent cancer.
  • 11. Patients must be able to take oral medications and capable of complying with treatment and follow up visit

Who cannot join

  • 1. Patients who have received other investigational drugs within 4 weeks or 5X t1/2 before first dose of study treatment.
  • 2. Patients have had palliative radiotherapy encompassing>20% of the bone marrow within 3 weeks of the first dose of study treatment.
  • 3. Patients have any known, persistent(>4 weeks)，≥Grade 3 anemia, neutrophil count decrease or platelet count decrease during the last chemotherapy.
  • 4. Patients have any known, persistent (>4 weeks), ≥ Grade 3 fatigue during the last chemotherapy.
  • 5. Patients have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
  • 6. Patients have symptomatic uncontrolled brain or leptomeningeal metastases. The patient have new or progressive signs or symptoms related to the CNS disease and not taking a stable dose of steroids or no steroids. A scan to confirm the absence of brain metastases is not required.
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  • 7. Patients have known hypersensitivity to the components of niraparib
  • 8. Patient have had major surgery within 3 weeks of fist dose treatment and patient must have recovered form any effects of any major surgery
  • 9. Patients have had diagnosis, detection, or treatment of invasive cancer other than ovarian cancer ≤2 years prior to enrollment(except basal or squamous cell carcinoma of the skin that has been definitively treated)
  • 10. Patients are considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to: 1. uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction 2. uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome or any psychiatric disorder that prohibits obtaining informed consent 3. immune deficiency (not including splenectomy) 4. HIV infection or active hepatitis(i.e. hepatitis B with HBV-DNA>500IU/ml or hepatitis C with positive HCV-RNA).
  • 11. Patients have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
  • 12. Patients have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • 13. Patients have current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study or interfere with patient's participation for the full duration of the study treatment or that makes it not in the best interest of the patient to participate

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

  • West China Second Iniversity Hospital

    Chengdu, Sichuan

  • Sun Yat-sen Memorial Hospital,Sun Yat-sen University

    Guangzhou, Guangdong

  • Sir Run Shaw Hospital, school of medicine, Zhejiang University

    Guangzhou, Zhejiang

  • Harbin Medical University

    Haerbin, Heilongjiang

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced and Relapsed Ovarian Cancer After 3 or 4 Previous Chemotherapies

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Conditions
Ovarian Cancer
Being tested
ZL-2306(Niraparib）
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(Niraparib）Drug

    Also called Zejula

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

Study groups in NCT04392102
Study groupRoleWhat they receive
ZL-2306(Niraparib)ExperimentalThe starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
Receives: Drug: ZL-2306(Niraparib）

What is being measured

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

  1. Objective Response Rate（ORR）

    The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1).

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Duration of Response (DoR)

    DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1).

    Measured: Up to 3 years

  2. Disease Control Rate (DCR)

    Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1). The exact method was used to calculate 95% confidence interval.

    Measured: Up to 3 years

  3. Progression Free Survival (PFS)

    Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1).

    Measured: Up to 3 years

  4. Overall Survival (OS)

    Overall Survival was defined as the time from the date of the first dose to the date of death by any cause.

    Measured: Up to 3 years

  5. Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE To evaluate the safety and tolerability of niraparib

    An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.

    Measured: Up to 3 years

Timeline

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

  1. First posted18 May 2020
  2. Study start4 Aug 2020
  3. Primary completion8 Apr 2021
  4. Study completion11 Aug 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04392102
Sponsor's protocol ID
ZL-2306-008
Status last verified
Aug 2022
First submitted
13 May 2020
Last updated
29 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZL-2306(Niraparib） in people with Ovarian Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 7 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective Response Rate（ORR） (time frame: Up to 3 years). 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 NCT04392102.

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 29 Aug 2022.

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