Recent Updates
Recently added Catalysts

AZD2281

Phase 2

Ovarian Neoplasms | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Dec 5, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00628251Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian CancerPHASE2 COMPLETED 97 — — Jul 30, 2008Sep 19, 2018Dec 5, 201924 United States, Australia +7
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Progression Free Survival (PFS)
Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)

Secondary Endpoints
Objective Response Rate (ORR)
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Disease Control Rate
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Overall Duration of Response
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD2281 Oral 200 mg BID
2ACTIVE_COMPARATORLiposomal Doxorubicin
3EXPERIMENTALAZD2281 Oral 400 mg BID
Interventions
NameTypeDescription
AZD2281DRUG400mg Oral twice daily
Liposomal DoxorubicinDRUG50mg/m2 Monthly Intravenous
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 130 Years
SexFEMALE
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Advanced ovarian cancer with positive BRCA1 or BRCA2 status * Progressive or recurrent disease after platinum-based chemotherapy * Measurable disease by RECIST Exclusion Criteria: * Previous anthracycline treatment * Brain metastases * Less than 28 days since last treatment ...

Countries:United StatesAustraliaBelgiumGermanyIsraelPolandSpainSwedenUnited Kingdom
Unlock Eligibility Criteria