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Niraparib

Phase 4FDA approved

Endometrial Carcinoma | Small molecule | Oncology |Zai Lab Limited|Trials Updated: Jan 5, 2024

Niraparib development status

FDA approval on record Mar 27, 2017 as Zejula
Approval holderGlaxosmithkline
ApplicationNDA208447
Highest phase Phase 4 run by University of Miami (NCT06412120)
Phase scored for ZLABPhase 2
Registered trials 75 across 41 sponsors since Jul 2013

Niraparib target and mechanism

Molecular targetPARP2, PARP1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Niraparib clinical trials

Niraparib · 1 trial · 2 indications

Phase 2 1
NCT04716686Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous CarcinomaEndometrial Carcinoma
RECRUITING83 Analytics
PHASE2RECRUITING
Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
Endometrial CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

PFS%(1 year)
assessed up to 12 months

for maintenance therapy arm

Objective Response Rate (ORR)
assessed up to 30months]

for maintenance therapy arm

Secondary Endpoints

PFS%(2 year)
assessed up to 24 months
Overall Survival (OS)
assessed up to 30 months
Median PFS
assessed up to 30 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Niraparib as maintenance therapy for Endometrial Serous CarcinomaEXPERIMENTALFor patients with baseline weight ≥ 77 kg and baseline platelets ≥ 150000/uL, a starting dose of 300 mg QD will be given; other patients will be given a starting dose of 200 mg QD. One treatment cycle is 28 days; follow-up and evaluation will be conducted every 2 cycles until the disease progression or patients cannot tolerate.
Niraparib as recurrent therapy for Endometrial CarcinomaEXPERIMENTALFor patients with baseline weight ≥ 77 kg and baseline platelets ≥ 150000/uL, a starting dose of 300 mg QD will be given; other patients will be given a starting dose of 200 mg QD. One treatment cycle is 28 days; follow-up and evaluation will be conducted every 2 cycles until the disease progression or patients cannot tolerate.

Interventions

NameTypeDescription
NiraparibDRUGPatients received oral niraparib 200/300 mg QD and every cycle (28 days) thereafter until disease progression.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Women aged 18 or above * Histological confirmation of serous endometrial cancer or other types of endometrial cancer * FIGO stage III-IV * ESC Patients have received at least 6 cycles of first-line platinum containing chemotherapy after surgery and achieved CR, PR or SD; ESC p...

Countries:China
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Frequently asked questions about Niraparib

What is Niraparib used for in endometrial carcinoma?

Niraparib is being studied as a monotherapy for the maintenance and recurrent treatment of endometrial serous carcinoma, a type of endometrial cancer. It is currently in Phase 2 clinical development for this indication. The drug is being evaluated in a controlled trial enrolling female patients aged 18 years and older.

What does Niraparib target?

Niraparib targets and inhibits PARP1 and PARP2, which are poly (ADP-ribose) polymerase enzymes involved in DNA repair. By inhibiting these targets, the drug is being investigated for its potential anti-cancer activity in endometrial serous carcinoma. This mechanism is the basis for its evaluation in the ongoing clinical trial.

Who is developing Niraparib?

Niraparib is being developed by Zai Lab Limited, a biopharmaceutical company listed on the stock exchange under the ticker ZLAB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with endometrial serous carcinoma.

What phase is Niraparib in for endometrial carcinoma?

Niraparib is in Phase 2 clinical development for the treatment of endometrial serous carcinoma. It is an investigational drug, meaning it has not yet been approved by regulatory authorities for this indication. The ongoing trial is actively recruiting participants in China.

What clinical trials is Niraparib in?

Niraparib is being studied in a Phase 2 clinical trial with the identifier NCT04716686. The trial is titled "Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma" and is currently recruiting participants. The study is enrolling 83 female patients with endometrial serous carcinoma in China.

Is Niraparib the same as any other drug?

Niraparib is a small molecule drug that is also known by its ChEMBL identifier CHEMBL1094636. It is being investigated as a monotherapy for endometrial serous carcinoma. The drug is not described as having any other alternative names in the clinical trial context.