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Adavosertib

Phase 2

Uterine Serous Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 14, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment109
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04590248A Study of Adavosertib as Treatment for Uterine Serous CarcinomaPHASE2 COMPLETED 109Nov 30, 2020Feb 7, 2023Aug 14, 202327 United States, Canada +3
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR)
up to 75 weeks

Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 for target lesions (TLs) and assessed by computed tomography (CT) or magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions; Partial response (PR), \>=30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.

Secondary Endpoints
Duration of Response (DoR)
up to 75 weeks
Depth of Response
Up to 75 weeks
Progression Free Survival (PFS)
Up to 75 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AdavosertibEXPERIMENTALSubjects will receive adavosertib 300 mg administered orally, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle.
Interventions
NameTypeDescription
AdavosertibDRUGThe subjects will receive oral adavosertib 300 mg, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle.
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Eligibility Criteria
Age Range18 Years — 130 Years
SexFEMALE
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: 1. Subjects must be aged ≥ 18 years of age inclusive, at the time of signing the informed consent. 2. Histologically confirmed recurrent or persistent USC. Subjects with carcinosarcomas are not eligible. 3. Evidence of measurable disease as per RECIST v1.1. 4. At least 1 prior p...

Countries:United StatesCanadaFranceItalySpain
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