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ZIO-201

Phase 1

Advanced Cancer | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Sep 17, 2009

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00421135A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced CancerPHASE1 COMPLETED 30Feb 1, 2006Oct 1, 2007Sep 17, 20092 United States
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Study Endpoints
Primary Endpoints
toxicities
6 months
Secondary Endpoints
pharmacokinetics
6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single ArmEXPERIMENTALZIO-201
Interventions
NameTypeDescription
ZIO-201DRUGZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Metastatic and /or unresectable disease state after previous standard chemotherapy

Countries:United States
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