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AZD7762

Phase 1

Solid Tumors | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Dec 6, 2010

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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00413686Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid MalignanciesPHASE1 COMPLETED 42Dec 1, 2006May 1, 2010Dec 6, 20102 United States
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine
Assessed after each course of treatment
Secondary Endpoints
To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.
Assessed after each course of treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD7762 monotherapy followed by AZD7762 + gemcitabine
Interventions
NameTypeDescription
AZD7762DRUGintravenous infusion
GemcitabineDRUGweekly intravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * ECOG performance status of 0 or 1 * Patient and tumor type must be suitable for treatment wi...

Countries:United States
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