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AZD8055

Phase 1

Solid Tumors | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jul 11, 2012

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 Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00731263A Study of Tor Kinase Inhibitor in Advanced TumorsPHASE1 COMPLETED 64Jul 1, 2008Nov 1, 2010Jul 11, 20124 United States, France +1
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Study Endpoints
Primary Endpoints
Safety and tolerability of AZD8055
Assessed at all visits
Secondary Endpoints
To identify early signals of anti-tumour activity
Visits 1, 5, and 9 and 11
To identify early signals of anti-tumor activity
Visits 1, 5, 9 and 13
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALThe study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.
Interventions
NameTypeDescription
AZD8055DRUGOral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma Part A only) * Cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria...

Countries:United StatesFranceUnited Kingdom
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