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ASG-5ME

Phase 1

Gastric Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Aug 27, 2013

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 Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01166490A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric AdenocarcinomaPHASE1 COMPLETED 51Jul 1, 2010Jul 1, 2013Aug 27, 20137 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events and laboratory abnormalities
Through 1 month after last dose
Secondary Endpoints
Best clinical response
Every 2 months
Overall and progression-free survival
Every month until death or study closure
Concentrations of ASG-5ME and metabolites in blood
Through 1 month after last dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALASG-5ME
Interventions
NameTypeDescription
ASG-5MEDRUG0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Pathologically confirmed metastatic pancreatic adenocarcinoma or pathologically confirmed AGS-5-positive gastric or gastric esophageal junction adenocarcinoma * Measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter ...

Countries:United States
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