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AZD8330

Phase 1

Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 24, 2011

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 Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00454090AZD8330 First Time in Man in Patients With Advanced MalignanciesPHASE1 COMPLETED 83Mar 1, 2007Mar 1, 2011Aug 24, 20113 United States, Norway
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Study Endpoints
Primary Endpoints
To assess safety and tolerability of AZD8330 in patient with advanced malignancies.
Outcome variables: Adverse Events, Clinical Chemistry, Haematology, Urinalysis, Vital signs, MUGA scans/echocardiography, ECGs, Ophthalmologic examination, O2 saturation
Secondary Endpoints
To determine the PK of AZD8330.
To investigate possible PD/PK relationships
To investigate effect of AZD8330 on pERK in PBMCs
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AZD8330DRUGoral tablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Cancer which is refractory to standard therapies, or no therapies exist; Exclusion Criteria: * Participated in radiotherapy, biological or chemotherapy within 21 days prior to study start; * Hasn't participated in investigation drug study within 30 days; * Brain metastases/s...

Countries:United StatesNorway
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