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ZL-2306

Phase 1

Ovarian Cancer | Small molecule | Oncology |Zai Lab Limited|Last Updated: Jan 24, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

ZL-2306 · 1 trial · 1 indication

Phase 1 1
NCT03551171The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian CancerOvarian Cancer
COMPLETED42 Analytics
PHASE1COMPLETED
The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer
Ovarian Cancer
NCT0355117142
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Study Endpoints

Primary Endpoints

Maximum plasma drug concentration (Cmax)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Time to reach Cmax (Tmax)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Terminal rate constant (λz)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Elimination half-life (t1/2)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to 24hrs (AUC (0-24))
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUC(0-t)) and from zero to infinity (AUC0-∞)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Apparent total body clearance of the drug from plasma (CL/F)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Apparent volume of distribution (Vd/f)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Mean residence time (MRT)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Degree of fluctuation (DF)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Maximum plasma drug concentration at steady-state (Css max)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Time to reach Css max (Tss max)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Minimum plasma drug concentration at steady-state (Css min)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to the end of drug administration (AUCss)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Steady-state apparent total body clearance of drug from plasma (Clss/F)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Accumulation ratio following multiple drug administration (RAC)
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
The plasma drug concentration before drug administration
From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)

Secondary Endpoints

Number of participants with adverse events as assessed by CTCAE v4.0
From the signing of ICF till the end of this study (30 days after the last administration of the study drug or the date to close the clinical trial database, whichever is earlier)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZL-2306 (niraparib)EXPERIMENTALSubjects will be randomised into 100mg, 200mg, 300mg dose group at the first day of the first cycle.

Interventions

NameTypeDescription
ZL-2306 (niraparib)DRUGAbout 30 subjects will be enrolled to the study, and randomised into 300mg, 200mg and 100mg dose groups (about 10 subjects per group). All subjects will be randomised into indicated dose group (300mg, 200mg or 100mg) at the first day of the first cycle. A single administration of ZL-2306 (niraparib) will be given to the subjects at indicated dose.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Signed informed consent . 2. Female, age ≥ 18 years. 3. Histologically confirmed diagnosis of FIGO stage III or IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 4. Has received no further than second-line platinum-based chemotherapy, and has clinical co...

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

What is ZL-2306 used for?

ZL-2306 is an investigational small molecule being studied for the treatment of ovarian cancer. It is currently in Phase 1 clinical development. The drug is being evaluated in patients with ovarian cancer to assess its pharmacokinetics, safety, and tolerability.

Who makes ZL-2306?

ZL-2306 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 China.

What phase is ZL-2306 in?

ZL-2306 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to evaluate the drug's pharmacokinetics, safety, and tolerability in patients with ovarian cancer.

What clinical trials is ZL-2306 in?

ZL-2306 has one completed clinical trial, identified as NCT03551171. This Phase 1 study evaluated the pharmacokinetics, safety, and tolerability of ZL-2306 in patients with ovarian cancer. The trial enrolled 42 female participants aged 18 years and older in China.

Is ZL-2306 the same as niraparib?

ZL-2306 is also known as niraparib. The clinical trial for ZL-2306 is titled 'The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer,' confirming that ZL-2306 and niraparib refer to the same drug.