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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705156
Recruitment Status : Active, not recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Zai Lab (Hong Kong), Ltd. ( Zai Lab (Shanghai) Co., Ltd. )

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Platinum-sensitive Relapsed Ovarian Cancer Drug: ZL-2306(nirapairb) Drug: Placebos Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 8, 2017
Actual Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 24, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ZL-2306
The starting dose is 300 mg or 200 mg based on patient's body weight.
 Drug: ZL-2306(nirapairb)
The starting dose is 300 mg or 200 mg based on patient's body weight.
Placebo Comparator: Placebo
The starting dose is the matched dose of placebo (3 capsules or 2 capsules).
 Drug: Placebos
The starting dose is the matched dose of placebo (3 capsules or 2 capsules).


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 35 months ]
    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.


Secondary Outcome Measures :
  1. Chemotherapy-free interval (CFI) [ Time Frame: 35 months ]
    It refers to the time from the last platinum-containing treatment to the start of the next anti-cancer treatment (excluding maintenance treatment);

  2. Time to first subsequent anti-cancer treatment (TFST) [ Time Frame: 35 months ]
    It refers to the time from the date of randomization in the study to the date when the first subsequent anti-tumor treatment starts.

  3. Overall survival (OS) [ Time Frame: 35 months ]
    It refers to the time from the date of randomization to death for any cause.


Eligibility Criteria
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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:

  • 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

Exclusion Criteria:

  • 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).
Contacts and Locations
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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): NCT03705156


Locations
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Sponsors and Collaborators
Zai Lab (Shanghai) Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zai Lab (Shanghai) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03705156    
Other Study ID Numbers: ZL-2306-001
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021

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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
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases