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AZD1152 part A

Phase 1

Tumors | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Apr 24, 2017

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
UNCONTROLLED
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00338182AZD1152 in Patients With Advanced Solid MalignanciesPHASE1 COMPLETED 43May 23, 2006Mar 1, 2017Apr 24, 20172 United States
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Study Endpoints
Primary Endpoints
The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG)
Throughout the study. Approximately 9 months for most patients.

Safety and tolerability will be assessed through the incidence of adverse events. Adverse events will include significant findings on vital signs, clinical chemistry/haematology, coagulation parameters and electrocardiograms (ECGs).

Secondary Endpoints
Assessment of pharmacodynamic biomarker changes
Biopsies of tumour at baseline and Cycle 1 [at pre-dose, after Screening to Day 1; and between Days 16-19 (preferrably within 24 hours of completing infusions on Day 17 (Part A) and Day 16 (Part B).]
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD1152EXPERIMENTALAZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment)
Interventions
NameTypeDescription
AZD1152 part ADRUG48-hour continuous intravenous infusion
AZD1152 part BDRUG2-hour intravenous infusion
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histological or cytological confirmation of a solid, malignant tumour * At least one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Exclusion Criteria: * Participation in an investigational drug stud...

Countries:United States
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