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ZL-2306 Niraparib)

Phase 2

Ovarian Cancer | Small molecule | Oncology |Zai Lab Limited|Last Updated: Aug 29, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

ZL-2306 Niraparib) · 1 trial · 1 indication

Phase 2 1
NCT04392102A Study of Niraparib in Patients With Relapsed Ovarian CancerOvarian Cancer
COMPLETED15 Analytics
PHASE2COMPLETED
A Study of Niraparib in Patients With Relapsed Ovarian Cancer
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate(ORR)
Up to 3 years

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).

Secondary Endpoints

Duration of Response (DoR)
Up to 3 years
Disease Control Rate (DCR)
Up to 3 years
Progression Free Survival (PFS)
Up to 3 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZL-2306(Niraparib)EXPERIMENTALThe starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Interventions

NameTypeDescription
ZL-2306(Niraparib)DRUGThe starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * 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 t...

Countries:China
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Frequently asked questions about ZL-2306 Niraparib)

What is ZL-2306 (Niraparib) used for?

ZL-2306 (Niraparib) is a small molecule being studied for the treatment of ovarian cancer. It is currently in Phase 2 clinical development for this indication. The drug is being investigated in patients with relapsed ovarian cancer.

Who makes ZL-2306 (Niraparib)?

ZL-2306 (Niraparib) is being developed by Zai Lab Limited, a biopharmaceutical company. Zai Lab's stock is traded under the ticker symbol ZLAB. The company is conducting clinical trials for this drug in ovarian cancer.

What phase is ZL-2306 (Niraparib) in?

ZL-2306 (Niraparib) is in Phase 2 clinical development for ovarian cancer. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed for this drug.

What clinical trials is ZL-2306 (Niraparib) in?

ZL-2306 (Niraparib) has one completed clinical trial, identified as NCT04392102. This Phase 2 study, titled "A Study of Niraparib in Patients With Relapsed Ovarian Cancer," was conducted in China and enrolled 15 female patients aged 18 years and older.

Is ZL-2306 (Niraparib) the same as Niraparib?

Yes, ZL-2306 (Niraparib) is the same drug as niraparib. The name ZL-2306 is the development code used by Zai Lab Limited for this drug, which is also known by its generic name, niraparib. It is being studied for ovarian cancer.