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Niraparib

Phase 2

Platinum-resistant Recurrent Clear Cell Ovarian Cancer | Small molecule | Oncology |Zai Lab Limited|Last Updated: Jan 31, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05130515Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.PHASE2 COMPLETED 6Dec 15, 2021Jan 1, 2023Jan 31, 20231 China
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Study Endpoints
Primary Endpoints
Objective response rate
at 6 months

The primary objective of this study is to determine the preliminary efficacy of administration of niraparib in combination with anlotinib in the treatment of platinum-resistant recurrent or platinum-refractory clear cell ovarian cancer, as measured by the objective response rate (ORR), which is a combination of CR (complete response, the target lesion completely disappeared over 4 weeks) and PR (partial response, the target lesions were reduced by more than 30% for more than 4 weeks).

Secondary Endpoints
The frequency and severity of adverse events
Baseline through 1.5 year
Duration of response
at 12 months
Time to response
at 6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment groupEXPERIMENTALNiraparib 200mg po QD day1\~21, Anlotinib 10mg po QD day1\~14
Interventions
NameTypeDescription
NiraparibDRUGNiraparib 200mg po QD, day1\~21
AnlotinibDRUGAnlotinib 10mg po QD, day1\~14, 3 weeks/cycle
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Eligibility Criteria
Age Range18 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. The patients understood the test process, signed the informed consent form and agreed to participate in the study. 2. 18 \~70 years old, female. 3. Histologically confirmed ovarian clear cell carcinoma. 4. The patients received platinum-based chemotherapy after primary debulk...

Countries:China
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